Bariatric Surgery Candidate, Obesity, Polyneuropathies
Conditions
Keywords
Metabolic syndrome, Exercise
Brief summary
The purpose of this research study is to evaluate how exercise and surgical weight loss affect how likely an individual is to develop peripheral neuropathy and other neurologic complications.
Detailed description
The length of this study, including screening is approximately 24 months. Patients at Bariatric Surgery Clinics will be recruited for this study. Both patients that decide to undergo bariatric surgery, and those that do not undergo surgery will be enrolled. Patients will be randomized to either a high intensity interval training (HIIT) or standard exercise regimen after eligibility is confirmed and the baseline visit is complete. All patients will complete follow-up appointments at 3 month, 12 months and 24 months. Patients that are randomized to the HIIT program will compete 2 supervised and 1 unsupervised training sessions a week for 24 months.
Interventions
OTHERHigh Intensity Interval Training (HIIT)
Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
OTHERRoutine Exercise
Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
PROCEDUREBariatric surgery
Patients will undergo bariatric surgery as part of their routine care
Sponsors
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The neuropathy outcomes assessors will be blinded to the exercise protocol that the patients are randomized to and the surgical status for the duration of the study.
Intervention model description
Patients will be assigned to one of 4 arms, bariatric surgery/HIIT, bariatric surgery/routine exercise, no bariatric surgery/HIIT, no bariatric surgery/routine exercise.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Attending a bariatric surgery clinic * BMI \> 35 with one comorbid condition present or BMI \> 40 without comorbid conditions present * Willing and capable to sign the Institutional Review Board (IRB) approved consent form and cooperate with the medical procedures for the study duration * Willing to accept random treatment assignment to HIIT or routine exercise counseling
Exclusion criteria
* History of distal symmetric polyneuropathy (DSP) from causes other than diabetes and/or the metabolic syndrome as determined through medical history, family history, history of medications, occupational history, history of exposure to toxins, physical and neurological examinations; * Use of warfarin, heparin, or other anticoagulants, which would increase the risk of complications from skin biopsy * Contraindication to HIIT participation including a failed exercise stress test * Participation in an experimental medication trial within 3 months of starting the study * Undergoing therapy for malignant disease other than basal-cell or squamous-cell skin cancer * Medical or psychiatric reason for not being a surgical candidate * Requiring a walking assist device; * Currently smoking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | Baseline, 3 months, 12 months and 24 months | Intraepidermal Nerve Fiber Density (IENFD) as assessed by 3mm skin biopsies at the proximal thigh. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | Baseline, 3 months, 12 months and 24 months | Intraepidermal Nerve Fiber Density (IENFD) as assessed by 3mm skin biopsies at the distal leg. |
| Corneal Confocal Microscopy (CCM) - Fiber Density | Baseline, 3 month, 12 months and 24 months | Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Corneal Nerve Fiber Density are quantified by fibers/mm2, a higher number represents a higher density of fibers. Lower numbers indicate worse neuropathy. |
| Corneal Confocal Microscopy (CCM) - Branch Density | Baseline, 3 month, 12 months and 24 months | Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Corneal Nerve Branch Density are quantified by branches/mm2, a higher number represents a higher density of branches. Lower numbers indicate worse neuropathy. |
| Corneal Confocal Microscopy (CCM) - Fiber Length | Baseline, 3 month, 12 months and 24 months | Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Corneal Nerve Fiber Length are quantified by mm/mm2, a higher number represents a higher total length of fibers. Lower numbers indicate worse neuropathy . |
| Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | Baseline, 3 month, 12 months and 24 months | Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Tortuosity Coefficient represents the total tortuosity (twisting/bending of nerves). As a coefficient the value is unitless, a higher value represents greater tortuosity. Lower numbers indicate worse neuropathy. |
| 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | Baseline, 3 month, 12 months and 24 months | 24-2 FDT was used to evaluate retinopathy using visual field deficits. Mean Deviation is presented below. Mean deviation is the average difference from normal expected value in the patients' particular age group. Lower values indicate more visual deficit. Higher values indicate fewer visual deficit. |
| 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | Baseline, 3 month, 12 months and 24 months | 24-2 FDT was used to evaluate retinopathy using visual field deficits. Foveal sensitivity is presented below. Foveal sensitivity is the measurement of the fovea's light detection ability. Lower values suggest visual field deficits. |
| 24-2 Frequency Doubling Technology (FDT) - Pattern SD | Baseline, 3 month, 12 months and 24 months | 24-2 FDT was used to evaluate retinopathy using visual field deficits. Pattern SD (PSD) is presented below. PSD provides information about localized loss. A higher PSD indicates a non-uniform sensitivity loss and visual field deficit. |
| Retinal Fundus Photography | Baseline, 3 month, 12 months and 24 months | As assessed by fundus photographs, participants were identified as either having retinopathy or not having retinopathy. Data is shown as number of people with retinopathy at a particular study visit. |
| Nerve Conduction Study (NCS) - Latency | Baseline and 24 months | Latency measures the time in millisecond between stimulation and the recording electrode. Was performed on sural, peroneal, and tibial nerves. No response and abnormal values indicate neuropathy. * Peroneal: 0 - No response, \>6.5 - Abnormal * Sural: 0 - No response, \>4.5 - Abnormal * Tibial: 0 - No response, \>6.1 - Abnormal |
| Nerve Conduction Study (NCS) - Motor Amplitude | Baseline and 24 months | Amplitude measures the height of electrical signal (waveform) in millivolts produced by the stimulated motor nerve. Was performed on peroneal, and tibial nerves. No response and abnormal values indicate neuropathy. * Peroneal: 0 - No response, \< 1.1 - Abnormal * Tibial: 0 - No response, \<1.1 - Abnormal |
| Nerve Conduction Study (NCS) - Sensory Amplitude | Baseline and 24 months | Amplitude measures the height of electrical signal (waveform) in microvolts produced by the stimulated sensory nerve. Was performed on sural nerve. No response and abnormal values indicate neuropathy. \* Sural: 0 - No response, \<4 - Abnormal |
| Nerve Conduction Study (NCS) - CV | Baseline and 24 months | Conduction velocity (V) measures the speed (m/s) at which the electrical impulse travels along the nerve. Was performed on peroneal nerves. No response and abnormal values indicate neuropathy. Abnormal values are \<36 or 39, depending on whether certain criteria applied to the participant. Data was not analyzed separately. |
| Nerve Conduction Study (NCS) - F Wave Index | Baseline and 24 months | F wave index measures the time in millisecond between stimulation at a distal (near the muscle) point and for the stimulus to travel to the spinal cord and back, allowing to assess the entire length of the nerve. Was performed on peroneal, and tibial nerves. No response and abnormal values indicate neuropathy. * Peroneal: 0 - No response, \>55 - Abnormal * Tibial: 0 - No response, \>55 - Abnormal |
| Cardiac Autonomic Neuropathy Testing-Deep Breathing/Exhalation to Inhalation (E:I) Ratio | Baseline and 24 months | Deep breathing/exhalation to inhalation (E:I) ratio were evaluated using PS monitor software. Values \< 1 are abnormal, indicative of cardiovascular autonomic neuropathy |
| Cardiac Autonomic Neuropathy Testing (30:15 Ratio) | Baseline and 24 months | Postural change-30:15 ratio was evaluated using PS monitor software. Values \< 1 are abnormal, indicative of cardiovascular autonomic neuropathy |
| Cardiac Autonomic Neuropathy Testing (Valsalva Ratio) | Baseline and 24 months | Valsalva ratio was evaluated using PS monitor software. Values \<= 1.10 are abnormal, indicative of cardiovascular autonomic neuropathy |
| Participants With Probable Polyneuropathy as Defined by the Toronto Definition of Probable Neuropathy | 24 months | Toronto definition of probable neuropathy is having at least 2 out of 3 of the following: abnormal sensory examination, reflexes, and patient-reported symptoms. Data is reported as number of participants who, under the Toronto definition, were identified as having probable polyneuropathy. |
| Michigan Neuropathy Screening Instrument (MNSI) | Baseline, 3 month, 12 months and 24 months | MNSI questionnaire is scored from 0-15, score \> 4 indicate neuropathy, higher scores indicate worse neuropathy. A score of 1 point is given for answers of "yes" for questions 1-6, 8-12, 14, and 15 and "no" for questions 7 and 13. |
| Michigan Neuropathy Screening Instrument (MNSI) - Exam | Baseline, 3 month, 12 months and 24 months | MNSI exam is scored from 0-8, score \>= 2.5 indicate neuropathy. Higher scores indicate worse neuropathy. |
| Michigan Neuropathy Screening Instrument (MNSI) - Index | Baseline, 3 month, 12 months and 24 months | The Michigan Neuropathy Screening Instrument (MNSI) index is a weighted composite score computed using the sum of the b-coefficients for all items within the MNSI questionnaire (15 questions) and MNSI exam (4 physical/visual exam). Range: -0.93, 7.39 Values \> 2.5407 are indicative of clinical neuropathy |
| Utah Early Neuropathy Score (UENS) | Baseline, 3 month, 12 months and 24 months | UENS is a composite score with five sections measuring multiple clinical measures of nerve injury. Sections are scored separately for each side (Right vs Left), and the total score is the sum across everything. Range: 0-42, higher score represents more severe polyneuropathy. |
| Modified Toronto Neuropathy Score (mTNS) | Baseline, 3 month, 12 months and 24 months | mTNS is a scale of 0-33 that measures neuropathy symptoms and exam findings. Higher scores indicate more severe polyneuropathy. |
| Survey of Autonomic Symptoms (SAS) | Baseline, 3 month, 12 months and 24 months | SAS evaluates the presence and magnitude of autonomic symptoms. Total impact score ranges from 0-60 (or up to 55 for participants to whom certain criteria did not apply). Higher score indicates worse autonomic neuropathy |
| Diabetic Neuropathy Score (DNS) | Baseline, 3 month, 12 months and 24 months | DNS is a questionnaire of neuropathy symptoms. Score ranges 0-4, \>/=1 indicates polyneuropathy. 0 indicates no polyneuropathy. |
| Short Form McGill Pain Questionnaire | Baseline, 3 months, 12 months, 24 months | Sum of the sensory score (0-30) and affective score (0-15) for a total score of 0-45. A higher score represents greater pain present. |
| Numerical Rating Scale for Pain | Baseline, 3 months, 12 months, 24 months | Participant reported pain scale with range 0-10, higher score indicates more pain. |
| Neuropathy Quality of Life (NeuroQOL) | Baseline, 3 months, 12 months, and 24 months | Neuropathy Quality of Life (NeuroQOL) evaluates symptoms and function in regard to quality of life over the past four weeks. Range 1-15, higher score indicates neuropathy having a greater impact on quality of life. |
| 8 Foot Get Up and Go Test | Baseline, 3 months, 12 months, and 24 months | This test measures in seconds how long it takes the participant to stand up from a seated position, walk around a cone places 8 feet away, and return to the chair and sit down. Less time indicates better speed, agility, and balance when moving. |
| Berg Balance Scale | Baseline, 3 months, 12 months, and 24 months | Berg Balance Scale measures participants' ability to balance and avoid falls. Scores range from 0-56, higher score indicates less likely to fall. |
| Modified Falls Efficacy Scale - Fall Evaluation | Baseline, 3 months, 12 months, and 24 months | Patient response indicating if they have fallen in the last year. Data is shown as number of people who have fallen in the last year. |
| Neurothesiometer | Baseline, 3 months, 12 months, and 24 months | Neurothesiometer is placed on the bottom of the great toe, and slowly increased until participant reports they can feel the vibration. The greater the microns, the less feeling the participant has, suggestive of worse sensory function. Value \> 25 Microns is indicative of neuropathy. There is no known maximum range. Lower values indicate better sensory function. |
| NIH Toolbox Cognitive Battery | Baseline and at 24 months | NIH Toolbox Cognition Fluid (Range: 0-100) - Composite score derived as an average across five cognitive domains. It's a fully adjusted T-score comparing the participant to a nationally representative sample, stratified by age and other demographics. Individual domain scores are fully adjusted T score with range 0-100 and measures the following- * Inhibitory Control and Attention - executive function, attention . * Dimensional Change Card Sort - executive function * Picture Sequence Memory - episodic memory * List Sorting Working Memory - working memory * Pattern Comparison - processing speed A T-score of 50 represents the population mean. A score of 60 indicates that the participant is 1 SD above the national average for individuals with similar demographic characteristics Higher scores reflect better cognitive functionality. No set clinical threshold, scores above mean indicate above average cognition for a given age group. |
| Rey Auditory Verbal Learning Test | Baseline and at 24 months | Used to evaluate verbal learning and memory using a list of 15 unrelated words presented to the participant over repeat trial. Includes 3 independent scales: * Auditory Learning (Total recall) - Measures memory and learning ability. Raw score range (0- 75) * Delayed Recall - Measures long term memory retention. Raw score range (0-15) * Recognition - Measures ability to recognize previously learned information. Raw score range (0-15). * Raw scores were converted to age-standardized Z-scores using 10-year age bands (e.g., 20-29, 30-39, 40-49, etc.), with a mean of 0 and standard deviation of 1. * A Z-score of 0 represents the population mean * For each scale, scores above 0 are better. Standard deviations above the mean indicates a better learning and memory ability for a given age group. No set clinical threshold, scores above mean indicate above average cognition for a given age group. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrian C Callaghan, MD, MS
University of Michigan, Department of Neurology
Participant flow
Recruitment details
Participants were recruited from Bariatric Surgery clinics in Ann Arbor and Detroit.
Pre-assignment details
140 participants were randomized to one of the four arms. Prior to randomization, participants had a screening visit, pre-baseline visit, and baseline visit to confirm eligibility. If participants qualified for the study, they were randomized and moved on with the study.
Participants by arm
| Arm | Count |
|---|---|
| No Bariatric Surgery/HIIT Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week. | 35 |
| Bariatric Surgery/Routine Exercise Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months. | 35 |
| Bariatric Surgery/HIIT Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week. | 35 |
| No Bariatric Surgery/Routine Exercise Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months. | 35 |
| Total | 140 |
Baseline characteristics
| Characteristic | No Bariatric Surgery/HIIT | Total | No Bariatric Surgery/Routine Exercise | Bariatric Surgery/HIIT | Bariatric Surgery/Routine Exercise |
|---|---|---|---|---|---|
| Age, Continuous | 50.54 years STANDARD_DEVIATION 7.56 | 50.31 years STANDARD_DEVIATION 7.1 | 51.14 years STANDARD_DEVIATION 8.08 | 49.91 years STANDARD_DEVIATION 5.77 | 49.66 years STANDARD_DEVIATION 6.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 137 Participants | 34 Participants | 35 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Bi/Multi Racial Non-Hispanic | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 13 Participants | 34 Participants | 14 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic White | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Middle Eastern | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native-American | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native-American/Black | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 19 Participants | 97 Participants | 17 Participants | 29 Participants | 32 Participants |
| Sex: Female, Male Female | 29 Participants | 108 Participants | 25 Participants | 28 Participants | 26 Participants |
| Sex: Female, Male Male | 6 Participants | 32 Participants | 10 Participants | 7 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 2 / 35 | 1 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 | 0 / 35 | 0 / 35 |
Outcome results
Primary
Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh
Intraepidermal Nerve Fiber Density (IENFD) as assessed by 3mm skin biopsies at the proximal thigh.
Time frame: Baseline, 3 months, 12 months and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | Baseline | 11.9 fibers/mm | Standard Deviation 3.9 |
| Bariatric Surgery/HIIT | Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | 3 Months | 12.6 fibers/mm | Standard Deviation 3.9 |
| Bariatric Surgery/HIIT | Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | 24 Months | 11.9 fibers/mm | Standard Deviation 6 |
| Bariatric Surgery/HIIT | Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | 12 Months | 11.5 fibers/mm | Standard Deviation 6.1 |
| Bariatric Surgery/Routine Exercise | Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | Baseline | 12.7 fibers/mm | Standard Deviation 4.4 |
| Bariatric Surgery/Routine Exercise | Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | 3 Months | 14.3 fibers/mm | Standard Deviation 5 |
| Bariatric Surgery/Routine Exercise | Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | 12 Months | 14.2 fibers/mm | Standard Deviation 6.2 |
| Bariatric Surgery/Routine Exercise | Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | 24 Months | 13.5 fibers/mm | Standard Deviation 6.2 |
| No Bariatric Surgery/HIIT | Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | 12 Months | 9.2 fibers/mm | Standard Deviation 4.2 |
| No Bariatric Surgery/HIIT | Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | Baseline | 9.8 fibers/mm | Standard Deviation 4.9 |
| No Bariatric Surgery/HIIT | Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | 24 Months | 10.3 fibers/mm | Standard Deviation 4.3 |
| No Bariatric Surgery/HIIT | Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | 3 Months | 9.9 fibers/mm | Standard Deviation 4.2 |
| No Bariatric Surgery/Routine Exercise | Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | 24 Months | 9.3 fibers/mm | Standard Deviation 3.8 |
| No Bariatric Surgery/Routine Exercise | Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | 3 Months | 10.6 fibers/mm | Standard Deviation 6 |
| No Bariatric Surgery/Routine Exercise | Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | 12 Months | 8.5 fibers/mm | Standard Deviation 4.4 |
| No Bariatric Surgery/Routine Exercise | Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh | Baseline | 11 fibers/mm | Standard Deviation 4.6 |
p-value: 0.1595% CI: [-4.63, 0.74]t-test, 2 sided
p-value: 0.0895% CI: [-4.98, 0.31]t-test, 2 sided
p-value: 0.1595% CI: [-4.43, 0.74]t-test, 2 sided
p-value: 0.6795% CI: [-0.02, 0.16]Mixed Models Analysis
p-value: 0.7795% CI: [0.002, 0.19]Mixed Models Analysis
p-value: 0.6995% CI: [-0.02, 0.16]Mixed Models Analysis
Secondary
24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB
24-2 FDT was used to evaluate retinopathy using visual field deficits. Foveal sensitivity is presented below. Foveal sensitivity is the measurement of the fovea's light detection ability. Lower values suggest visual field deficits.
Time frame: Baseline, 3 month, 12 months and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | Baseline-Foveal Sensitivity | 27.7 dB | Standard Deviation 4.5 |
| Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | 12 Months--Foveal Sensitivity | 28.1 dB | Standard Deviation 4 |
| Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | 3 Months--Foveal Sensitivity | 28.3 dB | Standard Deviation 5.3 |
| Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | 24 Months--Foveal Sensitivity | 27 dB | Standard Deviation 5.3 |
| Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | 12 Months--Foveal Sensitivity | 28.9 dB | Standard Deviation 3.6 |
| Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | 24 Months--Foveal Sensitivity | 28.2 dB | Standard Deviation 4.5 |
| Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | 3 Months--Foveal Sensitivity | 28.3 dB | Standard Deviation 4.5 |
| Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | Baseline-Foveal Sensitivity | 28.3 dB | Standard Deviation 3.5 |
| No Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | 3 Months--Foveal Sensitivity | 27.1 dB | Standard Deviation 4.1 |
| No Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | 12 Months--Foveal Sensitivity | 25.9 dB | Standard Deviation 5.5 |
| No Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | Baseline-Foveal Sensitivity | 26.9 dB | Standard Deviation 4.9 |
| No Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | 24 Months--Foveal Sensitivity | 26.7 dB | Standard Deviation 5 |
| No Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | 24 Months--Foveal Sensitivity | 26.5 dB | Standard Deviation 6.6 |
| No Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | Baseline-Foveal Sensitivity | 25.4 dB | Standard Deviation 5.9 |
| No Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | 12 Months--Foveal Sensitivity | 28.3 dB | Standard Deviation 4.6 |
| No Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB | 3 Months--Foveal Sensitivity | 26.4 dB | Standard Deviation 4.6 |
p-value: 0.26t-test, 2 sided
p-value: 0.58t-test, 2 sided
p-value: 0.97t-test, 2 sided
Secondary
24-2 Frequency Doubling Technology (FDT) - Mean Deviation
24-2 FDT was used to evaluate retinopathy using visual field deficits. Mean Deviation is presented below. Mean deviation is the average difference from normal expected value in the patients' particular age group. Lower values indicate more visual deficit. Higher values indicate fewer visual deficit.
Time frame: Baseline, 3 month, 12 months and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | Baseline-Mean Deviation | -1.6 dB | Standard Deviation 4.2 |
| Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | 3 Months-Mean Deviation | -1 dB | Standard Deviation 4.1 |
| Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | 12 Months-Mean Deviation | -0.9 dB | Standard Deviation 3.2 |
| Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | 24 Months-Mean Deviation | -1.1 dB | Standard Deviation 3.8 |
| Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | 3 Months-Mean Deviation | -1.5 dB | Standard Deviation 2.7 |
| Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | 12 Months-Mean Deviation | -1.3 dB | Standard Deviation 3.1 |
| Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | 24 Months-Mean Deviation | -0.7 dB | Standard Deviation 2.7 |
| Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | Baseline-Mean Deviation | -1.6 dB | Standard Deviation 2.7 |
| No Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | 12 Months-Mean Deviation | -2.4 dB | Standard Deviation 3.8 |
| No Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | 3 Months-Mean Deviation | -1.7 dB | Standard Deviation 4 |
| No Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | 24 Months-Mean Deviation | -2.3 dB | Standard Deviation 3.4 |
| No Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | Baseline-Mean Deviation | -2 dB | Standard Deviation 4.1 |
| No Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | 24 Months-Mean Deviation | -2.1 dB | Standard Deviation 4.8 |
| No Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | 3 Months-Mean Deviation | -2.8 dB | Standard Deviation 4.6 |
| No Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | Baseline-Mean Deviation | -2.5 dB | Standard Deviation 4 |
| No Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Mean Deviation | 12 Months-Mean Deviation | -1.5 dB | Standard Deviation 4.3 |
p-value: 0.9895% CI: [-2.12, 2.17]t-test, 2 sided
p-value: 0.7195% CI: [-2.26, 1.56]t-test, 2 sided
p-value: 0.9295% CI: [-2.1, 2.31]t-test, 2 sided
p-value: 0.9895% CI: [-0.08, 0.08]Mixed Models Analysis
p-value: 0.6695% CI: [-0.06, 0.1]Mixed Models Analysis
p-value: 0.6695% CI: [-0.1, 0.06]Mixed Models Analysis
Secondary
24-2 Frequency Doubling Technology (FDT) - Pattern SD
24-2 FDT was used to evaluate retinopathy using visual field deficits. Pattern SD (PSD) is presented below. PSD provides information about localized loss. A higher PSD indicates a non-uniform sensitivity loss and visual field deficit.
Time frame: Baseline, 3 month, 12 months and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Pattern SD | Baseline-Patter SD | 3.4 dB | Standard Deviation 1.1 |
| Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Pattern SD | 12 Months-Patter SD | 3.2 dB | Standard Deviation 1.1 |
| Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Pattern SD | 24 Months-Patter SD | 3.2 dB | Standard Deviation 0.8 |
| Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Pattern SD | 3 Months-Patter SD | 3.1 dB | Standard Deviation 1.1 |
| Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Pattern SD | 24 Months-Patter SD | 3.1 dB | Standard Deviation 0.7 |
| Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Pattern SD | Baseline-Patter SD | 3.1 dB | Standard Deviation 1.1 |
| Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Pattern SD | 3 Months-Patter SD | 3.2 dB | Standard Deviation 1.3 |
| Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Pattern SD | 12 Months-Patter SD | 3.3 dB | Standard Deviation 1.7 |
| No Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Pattern SD | Baseline-Patter SD | 3.3 dB | Standard Deviation 1.1 |
| No Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Pattern SD | 3 Months-Patter SD | 3.3 dB | Standard Deviation 1 |
| No Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Pattern SD | 24 Months-Patter SD | 3.5 dB | Standard Deviation 1.1 |
| No Bariatric Surgery/HIIT | 24-2 Frequency Doubling Technology (FDT) - Pattern SD | 12 Months-Patter SD | 3.5 dB | Standard Deviation 1.1 |
| No Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Pattern SD | Baseline-Patter SD | 3.7 dB | Standard Deviation 1.3 |
| No Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Pattern SD | 24 Months-Patter SD | 3.9 dB | Standard Deviation 1.7 |
| No Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Pattern SD | 12 Months-Patter SD | 3.6 dB | Standard Deviation 1.6 |
| No Bariatric Surgery/Routine Exercise | 24-2 Frequency Doubling Technology (FDT) - Pattern SD | 3 Months-Patter SD | 3.9 dB | Standard Deviation 1.7 |
p-value: 0.25t-test, 2 sided
p-value: 0.98t-test, 2 sided
p-value: 0.88t-test, 2 sided
Secondary
8 Foot Get Up and Go Test
This test measures in seconds how long it takes the participant to stand up from a seated position, walk around a cone places 8 feet away, and return to the chair and sit down. Less time indicates better speed, agility, and balance when moving.
Time frame: Baseline, 3 months, 12 months, and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | 8 Foot Get Up and Go Test | 3 Months | 6 Seconds | Standard Deviation 1.1 |
| Bariatric Surgery/HIIT | 8 Foot Get Up and Go Test | 12 Months | 6.2 Seconds | Standard Deviation 1.2 |
| Bariatric Surgery/HIIT | 8 Foot Get Up and Go Test | Baseline | 6.2 Seconds | Standard Deviation 1.5 |
| Bariatric Surgery/HIIT | 8 Foot Get Up and Go Test | 24 Months | 7.1 Seconds | Standard Deviation 3.9 |
| Bariatric Surgery/Routine Exercise | 8 Foot Get Up and Go Test | Baseline | 6.1 Seconds | Standard Deviation 1 |
| Bariatric Surgery/Routine Exercise | 8 Foot Get Up and Go Test | 3 Months | 5.9 Seconds | Standard Deviation 0.8 |
| Bariatric Surgery/Routine Exercise | 8 Foot Get Up and Go Test | 24 Months | 6 Seconds | Standard Deviation 0.9 |
| Bariatric Surgery/Routine Exercise | 8 Foot Get Up and Go Test | 12 Months | 5.6 Seconds | Standard Deviation 0.7 |
| No Bariatric Surgery/HIIT | 8 Foot Get Up and Go Test | 3 Months | 6.4 Seconds | Standard Deviation 1.3 |
| No Bariatric Surgery/HIIT | 8 Foot Get Up and Go Test | 24 Months | 6.5 Seconds | Standard Deviation 1 |
| No Bariatric Surgery/HIIT | 8 Foot Get Up and Go Test | Baseline | 6.4 Seconds | Standard Deviation 1.2 |
| No Bariatric Surgery/HIIT | 8 Foot Get Up and Go Test | 12 Months | 6.6 Seconds | Standard Deviation 1.6 |
| No Bariatric Surgery/Routine Exercise | 8 Foot Get Up and Go Test | 24 Months | 7 Seconds | Standard Deviation 1.2 |
| No Bariatric Surgery/Routine Exercise | 8 Foot Get Up and Go Test | 3 Months | 6.8 Seconds | Standard Deviation 1.5 |
| No Bariatric Surgery/Routine Exercise | 8 Foot Get Up and Go Test | 12 Months | 6.8 Seconds | Standard Deviation 1.3 |
| No Bariatric Surgery/Routine Exercise | 8 Foot Get Up and Go Test | Baseline | 6.6 Seconds | Standard Deviation 1.4 |
p-value: 0.58t-test, 2 sided
p-value: 0.8t-test, 2 sided
p-value: 0.86t-test, 2 sided
p-value: 0.46t-test, 2 sided
Secondary
Berg Balance Scale
Berg Balance Scale measures participants' ability to balance and avoid falls. Scores range from 0-56, higher score indicates less likely to fall.
Time frame: Baseline, 3 months, 12 months, and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Berg Balance Scale | Baseline | 55.41 score on a scale | Standard Deviation 1.16 |
| Bariatric Surgery/HIIT | Berg Balance Scale | 3 Months | 55.48 score on a scale | Standard Deviation 1.5 |
| Bariatric Surgery/HIIT | Berg Balance Scale | 12 Months | 54.88 score on a scale | Standard Deviation 2.12 |
| Bariatric Surgery/HIIT | Berg Balance Scale | 24 Months | 55.15 score on a scale | Standard Deviation 2.36 |
| Bariatric Surgery/Routine Exercise | Berg Balance Scale | 3 Months | 55.47 score on a scale | Standard Deviation 1.27 |
| Bariatric Surgery/Routine Exercise | Berg Balance Scale | 12 Months | 55.41 score on a scale | Standard Deviation 1.48 |
| Bariatric Surgery/Routine Exercise | Berg Balance Scale | 24 Months | 55.5 score on a scale | Standard Deviation 1.2 |
| Bariatric Surgery/Routine Exercise | Berg Balance Scale | Baseline | 55.53 score on a scale | Standard Deviation 1.02 |
| No Bariatric Surgery/HIIT | Berg Balance Scale | 12 Months | 54.88 score on a scale | Standard Deviation 2.12 |
| No Bariatric Surgery/HIIT | Berg Balance Scale | 3 Months | 55.48 score on a scale | Standard Deviation 1.5 |
| No Bariatric Surgery/HIIT | Berg Balance Scale | 24 Months | 55.15 score on a scale | Standard Deviation 2.36 |
| No Bariatric Surgery/HIIT | Berg Balance Scale | Baseline | 55.41 score on a scale | Standard Deviation 1.16 |
| No Bariatric Surgery/Routine Exercise | Berg Balance Scale | 24 Months | 55 score on a scale | Standard Deviation 1.89 |
| No Bariatric Surgery/Routine Exercise | Berg Balance Scale | 3 Months | 54.81 score on a scale | Standard Deviation 1.73 |
| No Bariatric Surgery/Routine Exercise | Berg Balance Scale | Baseline | 54.57 score on a scale | Standard Deviation 1.93 |
| No Bariatric Surgery/Routine Exercise | Berg Balance Scale | 12 Months | 54.65 score on a scale | Standard Deviation 1.6 |
p-value: 0.38t-test, 2 sided
p-value: 0.72t-test, 2 sided
p-value: 0.55t-test, 2 sided
p-value: 0.28t-test, 2 sided
Secondary
Cardiac Autonomic Neuropathy Testing (30:15 Ratio)
Postural change-30:15 ratio was evaluated using PS monitor software. Values \< 1 are abnormal, indicative of cardiovascular autonomic neuropathy
Time frame: Baseline and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Cardiac Autonomic Neuropathy Testing (30:15 Ratio) | Baseline | 1.1 ratio | Standard Deviation 0.2 |
| Bariatric Surgery/HIIT | Cardiac Autonomic Neuropathy Testing (30:15 Ratio) | 24 Months | 1.2 ratio | Standard Deviation 0.2 |
| Bariatric Surgery/Routine Exercise | Cardiac Autonomic Neuropathy Testing (30:15 Ratio) | 24 Months | 1.2 ratio | Standard Deviation 0.2 |
| Bariatric Surgery/Routine Exercise | Cardiac Autonomic Neuropathy Testing (30:15 Ratio) | Baseline | 1.1 ratio | Standard Deviation 0 |
| No Bariatric Surgery/HIIT | Cardiac Autonomic Neuropathy Testing (30:15 Ratio) | Baseline | 1.1 ratio | Standard Deviation 0.1 |
| No Bariatric Surgery/HIIT | Cardiac Autonomic Neuropathy Testing (30:15 Ratio) | 24 Months | 1.2 ratio | Standard Deviation 0.2 |
| No Bariatric Surgery/Routine Exercise | Cardiac Autonomic Neuropathy Testing (30:15 Ratio) | Baseline | 1.1 ratio | Standard Deviation 0.1 |
| No Bariatric Surgery/Routine Exercise | Cardiac Autonomic Neuropathy Testing (30:15 Ratio) | 24 Months | 1.3 ratio | Standard Deviation 0.2 |
p-value: 0.0795% CI: [-0.01, 0.31]t-test, 2 sided
p-value: 0.7295% CI: [-0.11, 0.16]t-test, 2 sided
p-value: 0.3395% CI: [-0.06, 0.19]t-test, 2 sided
Secondary
Cardiac Autonomic Neuropathy Testing-Deep Breathing/Exhalation to Inhalation (E:I) Ratio
Deep breathing/exhalation to inhalation (E:I) ratio were evaluated using PS monitor software. Values \< 1 are abnormal, indicative of cardiovascular autonomic neuropathy
Time frame: Baseline and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Cardiac Autonomic Neuropathy Testing-Deep Breathing/Exhalation to Inhalation (E:I) Ratio | Baseline | 1.3 ratio | Standard Deviation 0.1 |
| Bariatric Surgery/HIIT | Cardiac Autonomic Neuropathy Testing-Deep Breathing/Exhalation to Inhalation (E:I) Ratio | 24 Months | 1.2 ratio | Standard Deviation 0.2 |
| Bariatric Surgery/Routine Exercise | Cardiac Autonomic Neuropathy Testing-Deep Breathing/Exhalation to Inhalation (E:I) Ratio | 24 Months | 1.3 ratio | Standard Deviation 0.2 |
| Bariatric Surgery/Routine Exercise | Cardiac Autonomic Neuropathy Testing-Deep Breathing/Exhalation to Inhalation (E:I) Ratio | Baseline | 1.2 ratio | Standard Deviation 0.2 |
| No Bariatric Surgery/HIIT | Cardiac Autonomic Neuropathy Testing-Deep Breathing/Exhalation to Inhalation (E:I) Ratio | Baseline | 1.3 ratio | Standard Deviation 0.2 |
| No Bariatric Surgery/HIIT | Cardiac Autonomic Neuropathy Testing-Deep Breathing/Exhalation to Inhalation (E:I) Ratio | 24 Months | 1.3 ratio | Standard Deviation 0.2 |
| No Bariatric Surgery/Routine Exercise | Cardiac Autonomic Neuropathy Testing-Deep Breathing/Exhalation to Inhalation (E:I) Ratio | Baseline | 1.2 ratio | Standard Deviation 0.2 |
| No Bariatric Surgery/Routine Exercise | Cardiac Autonomic Neuropathy Testing-Deep Breathing/Exhalation to Inhalation (E:I) Ratio | 24 Months | 1.2 ratio | Standard Deviation 0.2 |
p-value: 0.9895% CI: [-0.01, 0.01]Mixed Models Analysis
p-value: 0.7995% CI: [-0.16, 0.129]t-test, 2 sided
p-value: 0.4695% CI: [-0.2, 0.01]t-test, 2 sided
p-value: 0.2495% CI: [-0.26, 0.07]t-test, 2 sided
p-value: 0.4995% CI: [-0.004, 0.01]Mixed Models Analysis
p-value: 0.1795% CI: [-0.002, 0.01]Mixed Models Analysis
Secondary
Cardiac Autonomic Neuropathy Testing (Valsalva Ratio)
Valsalva ratio was evaluated using PS monitor software. Values \<= 1.10 are abnormal, indicative of cardiovascular autonomic neuropathy
Time frame: Baseline and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Cardiac Autonomic Neuropathy Testing (Valsalva Ratio) | 24 Months | 1.3 ratio | Standard Deviation 0.2 |
| Bariatric Surgery/HIIT | Cardiac Autonomic Neuropathy Testing (Valsalva Ratio) | Baseline | 1.5 ratio | Standard Deviation 0.2 |
| Bariatric Surgery/Routine Exercise | Cardiac Autonomic Neuropathy Testing (Valsalva Ratio) | 24 Months | 1.4 ratio | Standard Deviation 0.3 |
| Bariatric Surgery/Routine Exercise | Cardiac Autonomic Neuropathy Testing (Valsalva Ratio) | Baseline | 1.5 ratio | Standard Deviation 0.2 |
| No Bariatric Surgery/HIIT | Cardiac Autonomic Neuropathy Testing (Valsalva Ratio) | Baseline | 1.4 ratio | Standard Deviation 0.2 |
| No Bariatric Surgery/HIIT | Cardiac Autonomic Neuropathy Testing (Valsalva Ratio) | 24 Months | 1.3 ratio | Standard Deviation 0.2 |
| No Bariatric Surgery/Routine Exercise | Cardiac Autonomic Neuropathy Testing (Valsalva Ratio) | Baseline | 1.4 ratio | Standard Deviation 0.2 |
| No Bariatric Surgery/Routine Exercise | Cardiac Autonomic Neuropathy Testing (Valsalva Ratio) | 24 Months | 1.4 ratio | Standard Deviation 0.3 |
p-value: 0.4695% CI: [-0.11, 0.24]t-test, 2 sided
p-value: 0.1595% CI: [-0.04, 0.31]t-test, 2 sided
p-value: 0.295% CI: [-0.06, 0.3]t-test, 2 sided
Secondary
Corneal Confocal Microscopy (CCM) - Branch Density
Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Corneal Nerve Branch Density are quantified by branches/mm2, a higher number represents a higher density of branches. Lower numbers indicate worse neuropathy.
Time frame: Baseline, 3 month, 12 months and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Branch Density | Baseline-Corneal Nerve Branch Density (branches/mm2) | 56.4 branches/mm^2 | Standard Deviation 30.7 |
| Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Branch Density | 24 Months-Corneal Nerve Branch Density (branches/mm2) | 124.7 branches/mm^2 | Standard Deviation 54.3 |
| Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Branch Density | 12 Months-Corneal Nerve Branch Density (branches/mm2) | 126.6 branches/mm^2 | Standard Deviation 68.6 |
| Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Branch Density | 3 Months-Corneal Nerve Branch Density (branches/mm2) | 62.2 branches/mm^2 | Standard Deviation 32 |
| Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Branch Density | 3 Months-Corneal Nerve Branch Density (branches/mm2) | 72.6 branches/mm^2 | Standard Deviation 34 |
| Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Branch Density | 12 Months-Corneal Nerve Branch Density (branches/mm2) | 137.4 branches/mm^2 | — |
| Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Branch Density | Baseline-Corneal Nerve Branch Density (branches/mm2) | 57.1 branches/mm^2 | Standard Deviation 24.6 |
| Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Branch Density | 24 Months-Corneal Nerve Branch Density (branches/mm2) | 129.8 branches/mm^2 | Standard Deviation 39.7 |
| No Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Branch Density | 3 Months-Corneal Nerve Branch Density (branches/mm2) | 62 branches/mm^2 | Standard Deviation 31.3 |
| No Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Branch Density | Baseline-Corneal Nerve Branch Density (branches/mm2) | 53.6 branches/mm^2 | Standard Deviation 31.9 |
| No Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Branch Density | 12 Months-Corneal Nerve Branch Density (branches/mm2) | 101.2 branches/mm^2 | Standard Deviation 57.9 |
| No Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Branch Density | 24 Months-Corneal Nerve Branch Density (branches/mm2) | 116.6 branches/mm^2 | Standard Deviation 49.1 |
| No Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Branch Density | 3 Months-Corneal Nerve Branch Density (branches/mm2) | 63.9 branches/mm^2 | Standard Deviation 37.2 |
| No Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Branch Density | Baseline-Corneal Nerve Branch Density (branches/mm2) | 54.7 branches/mm^2 | Standard Deviation 25.3 |
| No Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Branch Density | 24 Months-Corneal Nerve Branch Density (branches/mm2) | 127.1 branches/mm^2 | Standard Deviation 55.9 |
| No Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Branch Density | 12 Months-Corneal Nerve Branch Density (branches/mm2) | 116.8 branches/mm^2 | Standard Deviation 79 |
p-value: 0.62t-test, 2 sided
p-value: 0.95t-test, 2 sided
p-value: 0.59t-test, 2 sided
Secondary
Corneal Confocal Microscopy (CCM) - Fiber Density
Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Corneal Nerve Fiber Density are quantified by fibers/mm2, a higher number represents a higher density of fibers. Lower numbers indicate worse neuropathy.
Time frame: Baseline, 3 month, 12 months and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Fiber Density | 24 Months-Corneal Nerve Fiber Density (fibers/mm2) | 20.5 fibers/mm^2 | Standard Deviation 5.1 |
| Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Fiber Density | 3 Months-Corneal Nerve Fiber Density (fibers/mm2) | 20 fibers/mm^2 | Standard Deviation 6.5 |
| Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Fiber Density | 12 Months-Corneal Nerve Fiber Density (fibers/mm2) | 19.8 fibers/mm^2 | Standard Deviation 9.4 |
| Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Fiber Density | Baseline-Corneal Nerve Fiber Density (fibers/mm2) | 22.1 fibers/mm^2 | Standard Deviation 6.8 |
| Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Fiber Density | Baseline-Corneal Nerve Fiber Density (fibers/mm2) | 19.5 fibers/mm^2 | Standard Deviation 5.7 |
| Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Fiber Density | 24 Months-Corneal Nerve Fiber Density (fibers/mm2) | 20.2 fibers/mm^2 | Standard Deviation 3.9 |
| Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Fiber Density | 3 Months-Corneal Nerve Fiber Density (fibers/mm2) | 19.9 fibers/mm^2 | Standard Deviation 4.9 |
| Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Fiber Density | 12 Months-Corneal Nerve Fiber Density (fibers/mm2) | 20.7 fibers/mm^2 | Standard Deviation 5.2 |
| No Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Fiber Density | 12 Months-Corneal Nerve Fiber Density (fibers/mm2) | 17.2 fibers/mm^2 | Standard Deviation 6.3 |
| No Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Fiber Density | 3 Months-Corneal Nerve Fiber Density (fibers/mm2) | 19.3 fibers/mm^2 | Standard Deviation 6.5 |
| No Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Fiber Density | 24 Months-Corneal Nerve Fiber Density (fibers/mm2) | 19 fibers/mm^2 | Standard Deviation 5.5 |
| No Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Fiber Density | Baseline-Corneal Nerve Fiber Density (fibers/mm2) | 19.5 fibers/mm^2 | Standard Deviation 6.2 |
| No Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Fiber Density | 12 Months-Corneal Nerve Fiber Density (fibers/mm2) | 18.8 fibers/mm^2 | Standard Deviation 6.8 |
| No Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Fiber Density | 3 Months-Corneal Nerve Fiber Density (fibers/mm2) | 19.8 fibers/mm^2 | Standard Deviation 6.3 |
| No Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Fiber Density | Baseline-Corneal Nerve Fiber Density (fibers/mm2) | 22.4 fibers/mm^2 | Standard Deviation 5.4 |
| No Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Fiber Density | 24 Months-Corneal Nerve Fiber Density (fibers/mm2) | 18.8 fibers/mm^2 | Standard Deviation 5.7 |
p-value: 0.9795% CI: [-3.72, 3.85]t-test, 2 sided
p-value: 0.0395% CI: [-7.32, -0.31]t-test, 2 sided
p-value: 0.3895% CI: [-5.18, 2.05]t-test, 2 sided
Secondary
Corneal Confocal Microscopy (CCM) - Fiber Length
Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Corneal Nerve Fiber Length are quantified by mm/mm2, a higher number represents a higher total length of fibers. Lower numbers indicate worse neuropathy .
Time frame: Baseline, 3 month, 12 months and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Fiber Length | Baseline-Corneal Nerve Fiber Length (mm/mm2) | 18.6 mm/mm2 | Standard Deviation 6.1 |
| Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Fiber Length | 24 Months-Corneal Nerve Fiber Length (mm/mm2) | 25.2 mm/mm2 | Standard Deviation 6.8 |
| Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Fiber Length | 12 Months-Corneal Nerve Fiber Length (mm/mm2) | 25.7 mm/mm2 | Standard Deviation 7.5 |
| Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Fiber Length | 3 Months-Corneal Nerve Fiber Length (mm/mm2) | 19 mm/mm2 | Standard Deviation 5.9 |
| Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Fiber Length | Baseline-Corneal Nerve Fiber Length (mm/mm2) | 18.9 mm/mm2 | Standard Deviation 5.3 |
| Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Fiber Length | 3 Months-Corneal Nerve Fiber Length (mm/mm2) | 20.6 mm/mm2 | Standard Deviation 5.3 |
| Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Fiber Length | 12 Months-Corneal Nerve Fiber Length (mm/mm2) | 28 mm/mm2 | Standard Deviation 6.7 |
| Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Fiber Length | 24 Months-Corneal Nerve Fiber Length (mm/mm2) | 25.3 mm/mm2 | Standard Deviation 4.8 |
| No Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Fiber Length | Baseline-Corneal Nerve Fiber Length (mm/mm2) | 17.9 mm/mm2 | Standard Deviation 6.1 |
| No Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Fiber Length | 12 Months-Corneal Nerve Fiber Length (mm/mm2) | 23 mm/mm2 | Standard Deviation 8.1 |
| No Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Fiber Length | 3 Months-Corneal Nerve Fiber Length (mm/mm2) | 19.3 mm/mm2 | Standard Deviation 5.5 |
| No Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Fiber Length | 24 Months-Corneal Nerve Fiber Length (mm/mm2) | 24 mm/mm2 | Standard Deviation 6.9 |
| No Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Fiber Length | 3 Months-Corneal Nerve Fiber Length (mm/mm2) | 19.3 mm/mm2 | Standard Deviation 6.1 |
| No Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Fiber Length | 12 Months-Corneal Nerve Fiber Length (mm/mm2) | 24.7 mm/mm2 | Standard Deviation 8.7 |
| No Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Fiber Length | 24 Months-Corneal Nerve Fiber Length (mm/mm2) | 25.2 mm/mm2 | Standard Deviation 7.4 |
| No Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Fiber Length | Baseline-Corneal Nerve Fiber Length (mm/mm2) | 19.3 mm/mm2 | Standard Deviation 4.9 |
p-value: 0.8995% CI: [-4.26, 4.86]t-test, 2 sided
p-value: 0.8395% CI: [-4.64, 3.76]t-test, 2 sided
p-value: 0.8295% CI: [-4.27, 5.3]t-test, 2 sided
p-value: 0.5195% CI: [-0.11, 0.21]Mixed Models Analysis
p-value: 0.695% CI: [-0.11, 0.19]Mixed Models Analysis
p-value: 0.9995% CI: [-0.17, 0.17]Mixed Models Analysis
Secondary
Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient
Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Tortuosity Coefficient represents the total tortuosity (twisting/bending of nerves). As a coefficient the value is unitless, a higher value represents greater tortuosity. Lower numbers indicate worse neuropathy.
Time frame: Baseline, 3 month, 12 months and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | 12 Months-Corneal Tortuosity (coefficient value) | 20.8 Coefficient | Standard Deviation 7.2 |
| Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | 3 Months-Corneal Tortuosity (coefficient value) | 17.8 Coefficient | Standard Deviation 4.3 |
| Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | Baseline-Corneal Tortuosity (coefficient value) | 19.4 Coefficient | Standard Deviation 5.6 |
| Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | 24 Months-Corneal Tortuosity (coefficient value) | 20 Coefficient | Standard Deviation 10.1 |
| Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | 3 Months-Corneal Tortuosity (coefficient value) | 19.9 Coefficient | Standard Deviation 5.6 |
| Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | Baseline-Corneal Tortuosity (coefficient value) | 19 Coefficient | Standard Deviation 6.3 |
| Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | 12 Months-Corneal Tortuosity (coefficient value) | 20.6 Coefficient | Standard Deviation 5.6 |
| Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | 24 Months-Corneal Tortuosity (coefficient value) | 22 Coefficient | Standard Deviation 7.8 |
| No Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | Baseline-Corneal Tortuosity (coefficient value) | 18.6 Coefficient | Standard Deviation 6.7 |
| No Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | 24 Months-Corneal Tortuosity (coefficient value) | 21 Coefficient | Standard Deviation 4.9 |
| No Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | 12 Months-Corneal Tortuosity (coefficient value) | 20.1 Coefficient | Standard Deviation 7.3 |
| No Bariatric Surgery/HIIT | Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | 3 Months-Corneal Tortuosity (coefficient value) | 17.7 Coefficient | Standard Deviation 4.6 |
| No Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | 3 Months-Corneal Tortuosity (coefficient value) | 18.5 Coefficient | Standard Deviation 4.9 |
| No Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | 24 Months-Corneal Tortuosity (coefficient value) | 20.1 Coefficient | Standard Deviation 5.6 |
| No Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | Baseline-Corneal Tortuosity (coefficient value) | 19.2 Coefficient | Standard Deviation 4.9 |
| No Bariatric Surgery/Routine Exercise | Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient | 12 Months-Corneal Tortuosity (coefficient value) | 21.4 Coefficient | Standard Deviation 5.8 |
p-value: 0.82t-test, 2 sided
p-value: 0.21t-test, 2 sided
p-value: 0.33t-test, 2 sided
Secondary
Diabetic Neuropathy Score (DNS)
DNS is a questionnaire of neuropathy symptoms. Score ranges 0-4, \>/=1 indicates polyneuropathy. 0 indicates no polyneuropathy.
Time frame: Baseline, 3 month, 12 months and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Diabetic Neuropathy Score (DNS) | 3 Months | 1.1 score on a scale | Standard Deviation 1.4 |
| Bariatric Surgery/HIIT | Diabetic Neuropathy Score (DNS) | 12 Moths | 1 score on a scale | Standard Deviation 1.3 |
| Bariatric Surgery/HIIT | Diabetic Neuropathy Score (DNS) | 24 Months | 1.3 score on a scale | Standard Deviation 1.5 |
| Bariatric Surgery/HIIT | Diabetic Neuropathy Score (DNS) | Baseline | 1.1 score on a scale | Standard Deviation 1.3 |
| Bariatric Surgery/Routine Exercise | Diabetic Neuropathy Score (DNS) | 12 Moths | 0.6 score on a scale | Standard Deviation 0.9 |
| Bariatric Surgery/Routine Exercise | Diabetic Neuropathy Score (DNS) | 24 Months | 0.6 score on a scale | Standard Deviation 1 |
| Bariatric Surgery/Routine Exercise | Diabetic Neuropathy Score (DNS) | Baseline | 0.9 score on a scale | Standard Deviation 0.9 |
| Bariatric Surgery/Routine Exercise | Diabetic Neuropathy Score (DNS) | 3 Months | 0.6 score on a scale | Standard Deviation 1 |
| No Bariatric Surgery/HIIT | Diabetic Neuropathy Score (DNS) | 24 Months | 0.7 score on a scale | Standard Deviation 0.8 |
| No Bariatric Surgery/HIIT | Diabetic Neuropathy Score (DNS) | 12 Moths | 0.8 score on a scale | Standard Deviation 1.2 |
| No Bariatric Surgery/HIIT | Diabetic Neuropathy Score (DNS) | Baseline | 0.8 score on a scale | Standard Deviation 1 |
| No Bariatric Surgery/HIIT | Diabetic Neuropathy Score (DNS) | 3 Months | 0.8 score on a scale | Standard Deviation 1.2 |
| No Bariatric Surgery/Routine Exercise | Diabetic Neuropathy Score (DNS) | Baseline | 1.1 score on a scale | Standard Deviation 1.4 |
| No Bariatric Surgery/Routine Exercise | Diabetic Neuropathy Score (DNS) | 12 Moths | 0.9 score on a scale | Standard Deviation 1.1 |
| No Bariatric Surgery/Routine Exercise | Diabetic Neuropathy Score (DNS) | 3 Months | 0.9 score on a scale | Standard Deviation 1.4 |
| No Bariatric Surgery/Routine Exercise | Diabetic Neuropathy Score (DNS) | 24 Months | 1.1 score on a scale | Standard Deviation 1.4 |
p-value: 0.69t-test, 2 sided
p-value: 0.24t-test, 2 sided
p-value: 0.45t-test, 2 sided
p-value: 0.84t-test, 2 sided
Secondary
Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg.
Intraepidermal Nerve Fiber Density (IENFD) as assessed by 3mm skin biopsies at the distal leg.
Time frame: Baseline, 3 months, 12 months and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | Baseline | 6.3 fibers/mm | Standard Deviation 4 |
| Bariatric Surgery/HIIT | Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | 3 Months | 7.3 fibers/mm | Standard Deviation 4.1 |
| Bariatric Surgery/HIIT | Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | 12 Months | 7.7 fibers/mm | Standard Deviation 5.2 |
| Bariatric Surgery/HIIT | Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | 24 Months | 6.9 fibers/mm | Standard Deviation 4.5 |
| Bariatric Surgery/Routine Exercise | Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | 3 Months | 6.2 fibers/mm | Standard Deviation 4.1 |
| Bariatric Surgery/Routine Exercise | Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | 12 Months | 8.7 fibers/mm | Standard Deviation 5.4 |
| Bariatric Surgery/Routine Exercise | Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | 24 Months | 7.4 fibers/mm | Standard Deviation 4.4 |
| Bariatric Surgery/Routine Exercise | Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | Baseline | 6.8 fibers/mm | Standard Deviation 4.3 |
| No Bariatric Surgery/HIIT | Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | 12 Months | 6.4 fibers/mm | Standard Deviation 3.6 |
| No Bariatric Surgery/HIIT | Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | 3 Months | 6.3 fibers/mm | Standard Deviation 3.6 |
| No Bariatric Surgery/HIIT | Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | 24 Months | 6.4 fibers/mm | Standard Deviation 3.8 |
| No Bariatric Surgery/HIIT | Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | Baseline | 7.3 fibers/mm | Standard Deviation 4.1 |
| No Bariatric Surgery/Routine Exercise | Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | 24 Months | 5.8 fibers/mm | Standard Deviation 4.1 |
| No Bariatric Surgery/Routine Exercise | Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | 3 Months | 5.5 fibers/mm | Standard Deviation 3.8 |
| No Bariatric Surgery/Routine Exercise | Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | Baseline | 5.7 fibers/mm | Standard Deviation 3.8 |
| No Bariatric Surgery/Routine Exercise | Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg. | 12 Months | 6.4 fibers/mm | Standard Deviation 5.5 |
p-value: 0.2795% CI: [-2.77, 0.79]t-test, 2 sided
p-value: 0.1895% CI: [-2.71, 0.53]t-test, 2 sided
p-value: 0.2195% CI: [-0.82, 3.48]t-test, 2 sided
p-value: 0.6695% CI: [-0.05, 0.09]Mixed Models Analysis
p-value: 0.2595% CI: [-0.02, 0.11]Mixed Models Analysis
p-value: 0.0995% CI: [-0.13, 0.01]Mixed Models Analysis
Secondary
Michigan Neuropathy Screening Instrument (MNSI)
MNSI questionnaire is scored from 0-15, score \> 4 indicate neuropathy, higher scores indicate worse neuropathy. A score of 1 point is given for answers of yes for questions 1-6, 8-12, 14, and 15 and no for questions 7 and 13.
Time frame: Baseline, 3 month, 12 months and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) | 24 Months Questionnaire | 3.2 score on a scale | Standard Deviation 2.6 |
| Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) | Baseline Questionnaire | 2.5 score on a scale | Standard Deviation 2.4 |
| Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) | 3 Months Questionnaire | 2.5 score on a scale | Standard Deviation 2.7 |
| Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) | 12 Months Questionnaire | 2.7 score on a scale | Standard Deviation 2.9 |
| Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) | 12 Months Questionnaire | 2.1 score on a scale | Standard Deviation 2.2 |
| Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) | 3 Months Questionnaire | 2 score on a scale | Standard Deviation 1.9 |
| Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) | Baseline Questionnaire | 2.5 score on a scale | Standard Deviation 1.7 |
| Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) | 24 Months Questionnaire | 2.3 score on a scale | Standard Deviation 2 |
| No Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) | 3 Months Questionnaire | 2.5 score on a scale | Standard Deviation 2.7 |
| No Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) | 12 Months Questionnaire | 2.3 score on a scale | Standard Deviation 2 |
| No Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) | Baseline Questionnaire | 2.4 score on a scale | Standard Deviation 2.2 |
| No Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) | 24 Months Questionnaire | 1.8 score on a scale | Standard Deviation 1.7 |
| No Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) | Baseline Questionnaire | 2.8 score on a scale | Standard Deviation 2.1 |
| No Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) | 24 Months Questionnaire | 2.8 score on a scale | Standard Deviation 2 |
| No Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) | 12 Months Questionnaire | 2.8 score on a scale | Standard Deviation 2.1 |
| No Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) | 3 Months Questionnaire | 2.3 score on a scale | Standard Deviation 2.2 |
Comparison: Questionnairep-value: 0.2195% CI: [-1.5, 0.35]t-test, 2 sided
Comparison: Questionnairep-value: 0.8595% CI: [-0.98, 0.8]t-test, 2 sided
Comparison: Questionnairep-value: 0.3795% CI: [-0.58, 1.5]t-test, 2 sided
Comparison: Questionnairep-value: 0.7895% CI: [0.99, 1.02]Mixed Models Analysis
Comparison: Questionnairep-value: 0.5395% CI: [0.98, 1.01]Mixed Models Analysis
Comparison: Questionnairep-value: 0.0895% CI: [0.96, 1]Mixed Models Analysis
Secondary
Michigan Neuropathy Screening Instrument (MNSI) - Exam
MNSI exam is scored from 0-8, score \>= 2.5 indicate neuropathy. Higher scores indicate worse neuropathy.
Time frame: Baseline, 3 month, 12 months and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) - Exam | 24 Months Exam | 0.9 score on a scale | Standard Deviation 1.3 |
| Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) - Exam | Baseline Exam | 1 score on a scale | Standard Deviation 1.4 |
| Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) - Exam | 12 Months Exam | 1.1 score on a scale | Standard Deviation 1.3 |
| Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) - Exam | 3 Months Exam | 1 score on a scale | Standard Deviation 1.4 |
| Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) - Exam | 12 Months Exam | 1 score on a scale | Standard Deviation 1.3 |
| Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) - Exam | Baseline Exam | 0.9 score on a scale | Standard Deviation 1.2 |
| Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) - Exam | 3 Months Exam | 0.4 score on a scale | Standard Deviation 0.7 |
| Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) - Exam | 24 Months Exam | 0.6 score on a scale | Standard Deviation 0.9 |
| No Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) - Exam | Baseline Exam | 1.1 score on a scale | Standard Deviation 1.4 |
| No Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) - Exam | 12 Months Exam | 1.1 score on a scale | Standard Deviation 1.7 |
| No Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) - Exam | 24 Months Exam | 1.3 score on a scale | Standard Deviation 1.8 |
| No Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) - Exam | 3 Months Exam | 1.2 score on a scale | Standard Deviation 1.8 |
| No Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) - Exam | 3 Months Exam | 1.5 score on a scale | Standard Deviation 1.6 |
| No Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) - Exam | 12 Months Exam | 1.4 score on a scale | Standard Deviation 1.7 |
| No Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) - Exam | Baseline Exam | 1.3 score on a scale | Standard Deviation 1.7 |
| No Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) - Exam | 24 Months Exam | 1.8 score on a scale | Standard Deviation 1.5 |
p-value: 0.01t-test, 2 sided
p-value: 0.04t-test, 2 sided
p-value: 0.47t-test, 2 sided
p-value: 0.1895% CI: [0.96, 1.01]Mixed Models Analysis
p-value: 0.5295% CI: [0.96, 1.02]Mixed Models Analysis
p-value: 0.8795% CI: [0.97, 1.02]Mixed Models Analysis
Secondary
Michigan Neuropathy Screening Instrument (MNSI) - Index
The Michigan Neuropathy Screening Instrument (MNSI) index is a weighted composite score computed using the sum of the b-coefficients for all items within the MNSI questionnaire (15 questions) and MNSI exam (4 physical/visual exam). Range: -0.93, 7.39 Values \> 2.5407 are indicative of clinical neuropathy
Time frame: Baseline, 3 month, 12 months and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) - Index | 24 Months Index | 1.7 MNSI Score | Standard Deviation 1.5 |
| Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) - Index | Baseline Index | 1.6 MNSI Score | Standard Deviation 1.3 |
| Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) - Index | 3 Months Index | 1.6 MNSI Score | Standard Deviation 1.3 |
| Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) - Index | 12 Months Index | 1.7 MNSI Score | Standard Deviation 1.6 |
| Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) - Index | 3 Months Index | 1.1 MNSI Score | Standard Deviation 1 |
| Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) - Index | 12 Months Index | 1.3 MNSI Score | Standard Deviation 1.1 |
| Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) - Index | Baseline Index | 1.5 MNSI Score | Standard Deviation 0.9 |
| Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) - Index | 24 Months Index | 1.5 MNSI Score | Standard Deviation 1.5 |
| No Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) - Index | 12 Months Index | 1.6 MNSI Score | Standard Deviation 1.3 |
| No Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) - Index | Baseline Index | 1.4 MNSI Score | Standard Deviation 1.3 |
| No Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) - Index | 3 Months Index | 1.7 MNSI Score | Standard Deviation 1.4 |
| No Bariatric Surgery/HIIT | Michigan Neuropathy Screening Instrument (MNSI) - Index | 24 Months Index | 1.9 MNSI Score | Standard Deviation 1.3 |
| No Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) - Index | 12 Months Index | 2 MNSI Score | Standard Deviation 1.5 |
| No Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) - Index | 24 Months Index | 1.9 MNSI Score | Standard Deviation 1.2 |
| No Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) - Index | Baseline Index | 1.8 MNSI Score | Standard Deviation 1.3 |
| No Bariatric Surgery/Routine Exercise | Michigan Neuropathy Screening Instrument (MNSI) - Index | 3 Months Index | 1.8 MNSI Score | Standard Deviation 1.5 |
p-value: 0.2t-test, 2 sided
p-value: 0.57t-test, 2 sided
p-value: 0.61t-test, 2 sided
Secondary
Modified Falls Efficacy Scale - Fall Evaluation
Patient response indicating if they have fallen in the last year. Data is shown as number of people who have fallen in the last year.
Time frame: Baseline, 3 months, 12 months, and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bariatric Surgery/HIIT | Modified Falls Efficacy Scale - Fall Evaluation | 3 Months | 8 Participants |
| Bariatric Surgery/HIIT | Modified Falls Efficacy Scale - Fall Evaluation | Baseline | 8 Participants |
| Bariatric Surgery/HIIT | Modified Falls Efficacy Scale - Fall Evaluation | 12 Months | 7 Participants |
| Bariatric Surgery/HIIT | Modified Falls Efficacy Scale - Fall Evaluation | 24 Months | 6 Participants |
| Bariatric Surgery/Routine Exercise | Modified Falls Efficacy Scale - Fall Evaluation | 3 Months | 8 Participants |
| Bariatric Surgery/Routine Exercise | Modified Falls Efficacy Scale - Fall Evaluation | 12 Months | 2 Participants |
| Bariatric Surgery/Routine Exercise | Modified Falls Efficacy Scale - Fall Evaluation | Baseline | 9 Participants |
| Bariatric Surgery/Routine Exercise | Modified Falls Efficacy Scale - Fall Evaluation | 24 Months | 8 Participants |
| No Bariatric Surgery/HIIT | Modified Falls Efficacy Scale - Fall Evaluation | Baseline | 9 Participants |
| No Bariatric Surgery/HIIT | Modified Falls Efficacy Scale - Fall Evaluation | 3 Months | 8 Participants |
| No Bariatric Surgery/HIIT | Modified Falls Efficacy Scale - Fall Evaluation | 24 Months | 7 Participants |
| No Bariatric Surgery/HIIT | Modified Falls Efficacy Scale - Fall Evaluation | 12 Months | 2 Participants |
| No Bariatric Surgery/Routine Exercise | Modified Falls Efficacy Scale - Fall Evaluation | 24 Months | 6 Participants |
| No Bariatric Surgery/Routine Exercise | Modified Falls Efficacy Scale - Fall Evaluation | 12 Months | 10 Participants |
| No Bariatric Surgery/Routine Exercise | Modified Falls Efficacy Scale - Fall Evaluation | 3 Months | 5 Participants |
| No Bariatric Surgery/Routine Exercise | Modified Falls Efficacy Scale - Fall Evaluation | Baseline | 12 Participants |
p-value: 0.54t-test, 2 sided
p-value: 1t-test, 2 sided
p-value: 0.77t-test, 2 sided
p-value: 0.24t-test, 2 sided
Secondary
Modified Toronto Neuropathy Score (mTNS)
mTNS is a scale of 0-33 that measures neuropathy symptoms and exam findings. Higher scores indicate more severe polyneuropathy.
Time frame: Baseline, 3 month, 12 months and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Modified Toronto Neuropathy Score (mTNS) | 3 Months | 2.1 score on a scale | Standard Deviation 4.2 |
| Bariatric Surgery/HIIT | Modified Toronto Neuropathy Score (mTNS) | Baseline | 3.8 score on a scale | Standard Deviation 7.7 |
| Bariatric Surgery/HIIT | Modified Toronto Neuropathy Score (mTNS) | 12 Months | 3.5 score on a scale | Standard Deviation 5.9 |
| Bariatric Surgery/HIIT | Modified Toronto Neuropathy Score (mTNS) | 24 Months | 4.4 score on a scale | Standard Deviation 6.4 |
| Bariatric Surgery/Routine Exercise | Modified Toronto Neuropathy Score (mTNS) | Baseline | 1.5 score on a scale | Standard Deviation 2.6 |
| Bariatric Surgery/Routine Exercise | Modified Toronto Neuropathy Score (mTNS) | 12 Months | 1.8 score on a scale | Standard Deviation 3 |
| Bariatric Surgery/Routine Exercise | Modified Toronto Neuropathy Score (mTNS) | 3 Months | 1.3 score on a scale | Standard Deviation 1.5 |
| Bariatric Surgery/Routine Exercise | Modified Toronto Neuropathy Score (mTNS) | 24 Months | 2.6 score on a scale | Standard Deviation 2.9 |
| No Bariatric Surgery/HIIT | Modified Toronto Neuropathy Score (mTNS) | 12 Months | 2.3 score on a scale | Standard Deviation 4.1 |
| No Bariatric Surgery/HIIT | Modified Toronto Neuropathy Score (mTNS) | Baseline | 2.1 score on a scale | Standard Deviation 3.4 |
| No Bariatric Surgery/HIIT | Modified Toronto Neuropathy Score (mTNS) | 3 Months | 2.1 score on a scale | Standard Deviation 4.4 |
| No Bariatric Surgery/HIIT | Modified Toronto Neuropathy Score (mTNS) | 24 Months | 1.4 score on a scale | Standard Deviation 1.9 |
| No Bariatric Surgery/Routine Exercise | Modified Toronto Neuropathy Score (mTNS) | 3 Months | 2.8 score on a scale | Standard Deviation 4.7 |
| No Bariatric Surgery/Routine Exercise | Modified Toronto Neuropathy Score (mTNS) | 12 Months | 3.4 score on a scale | Standard Deviation 5.9 |
| No Bariatric Surgery/Routine Exercise | Modified Toronto Neuropathy Score (mTNS) | 24 Months | 3.2 score on a scale | Standard Deviation 3.9 |
| No Bariatric Surgery/Routine Exercise | Modified Toronto Neuropathy Score (mTNS) | Baseline | 3.5 score on a scale | Standard Deviation 5.7 |
p-value: 0.7895% CI: [-3.41, 4.45]t-test, 2 sided
p-value: 0.6395% CI: [-3.14, 1.95]t-test, 2 sided
p-value: 0.4395% CI: [-1.55, 3.58]t-test, 2 sided
p-value: 0.4395% CI: [0.98, 1.01]Mixed Models Analysis
p-value: 0.8395% CI: [0.98, 1.02]Mixed Models Analysis
p-value: <0.0195% CI: [0.94, 0.99]Mixed Models Analysis
Secondary
Nerve Conduction Study (NCS) - CV
Conduction velocity (V) measures the speed (m/s) at which the electrical impulse travels along the nerve. Was performed on peroneal nerves. No response and abnormal values indicate neuropathy. Abnormal values are \<36 or 39, depending on whether certain criteria applied to the participant. Data was not analyzed separately.
Time frame: Baseline and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - CV | Baseline-Peroneal CV (m/s) | 46.91 m/s | Standard Deviation 4.14 |
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - CV | 24 Months-Peroneal CV (m/s) | 46.96 m/s | Standard Deviation 5.58 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - CV | 24 Months-Peroneal CV (m/s) | 47.48 m/s | Standard Deviation 4.25 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - CV | Baseline-Peroneal CV (m/s) | 45.37 m/s | Standard Deviation 4.27 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - CV | Baseline-Peroneal CV (m/s) | 46.49 m/s | Standard Deviation 4.39 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - CV | 24 Months-Peroneal CV (m/s) | 44.69 m/s | Standard Deviation 5.43 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - CV | Baseline-Peroneal CV (m/s) | 45.47 m/s | Standard Deviation 6.38 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - CV | 24 Months-Peroneal CV (m/s) | 45.96 m/s | Standard Deviation 5.24 |
Comparison: Measure - Peroneal CV (m/s)p-value: 0.82t-test, 2 sided
Comparison: Measure - Peroneal CV (m/s)p-value: 0.27t-test, 2 sided
Comparison: Measure - Peroneal CV (m/s)p-value: 0.52t-test, 2 sided
Secondary
Nerve Conduction Study (NCS) - F Wave Index
F wave index measures the time in millisecond between stimulation at a distal (near the muscle) point and for the stimulus to travel to the spinal cord and back, allowing to assess the entire length of the nerve. Was performed on peroneal, and tibial nerves. No response and abnormal values indicate neuropathy. * Peroneal: 0 - No response, \>55 - Abnormal * Tibial: 0 - No response, \>55 - Abnormal
Time frame: Baseline and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - F Wave Index | 24 Months-Tibial F wave index (ms) | 50.56 ms | Standard Deviation 5.7 |
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - F Wave Index | 24 Months-Peroneal F wave index (ms) | 48.45 ms | Standard Deviation 4.57 |
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - F Wave Index | Baseline-Peroneal F wave index (ms) | 48.29 ms | Standard Deviation 6.99 |
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - F Wave Index | Baseline-Tibial F wave index (ms) | 50.84 ms | Standard Deviation 8.88 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - F Wave Index | Baseline-Peroneal F wave index (ms) | 49.57 ms | Standard Deviation 4.54 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - F Wave Index | Baseline-Tibial F wave index (ms) | 51.92 ms | Standard Deviation 5.78 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - F Wave Index | 24 Months-Tibial F wave index (ms) | 50.41 ms | Standard Deviation 6.06 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - F Wave Index | 24 Months-Peroneal F wave index (ms) | 48.5 ms | Standard Deviation 5.4 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - F Wave Index | Baseline-Tibial F wave index (ms) | 52.45 ms | Standard Deviation 5.4 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - F Wave Index | Baseline-Peroneal F wave index (ms) | 49.28 ms | Standard Deviation 5.73 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - F Wave Index | 24 Months-Tibial F wave index (ms) | 50.61 ms | Standard Deviation 5.32 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - F Wave Index | 24 Months-Peroneal F wave index (ms) | 48.95 ms | Standard Deviation 5.18 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - F Wave Index | 24 Months-Peroneal F wave index (ms) | 50.07 ms | Standard Deviation 6.95 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - F Wave Index | Baseline-Peroneal F wave index (ms) | 48.91 ms | Standard Deviation 9.35 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - F Wave Index | Baseline-Tibial F wave index (ms) | 50.8 ms | Standard Deviation 9.21 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - F Wave Index | 24 Months-Tibial F wave index (ms) | 51.88 ms | Standard Deviation 5.12 |
Comparison: Measure - Peroneal F wave index (ms)p-value: 0.32t-test, 2 sided
Comparison: Measure - Peroneal F wave index (ms)p-value: 0.43t-test, 2 sided
Comparison: Measure - Peroneal F wave index (ms)p-value: 0.48t-test, 2 sided
Comparison: Measure - Tibial F wave index (ms)p-value: 0.75t-test, 2 sided
Comparison: Measure - Tibial F wave index (ms)p-value: 0.09t-test, 2 sided
Comparison: Measure - Tibial F wave index (ms)p-value: 0.03t-test, 2 sided
Secondary
Nerve Conduction Study (NCS) - Latency
Latency measures the time in millisecond between stimulation and the recording electrode. Was performed on sural, peroneal, and tibial nerves. No response and abnormal values indicate neuropathy. * Peroneal: 0 - No response, \>6.5 - Abnormal * Sural: 0 - No response, \>4.5 - Abnormal * Tibial: 0 - No response, \>6.1 - Abnormal
Time frame: Baseline and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Latency | Baseline-Peroneal distal motor latency (ms) | 4.6 ms | Standard Deviation 0.8 |
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Latency | 24 Months-Sural peak latency (ms) | 3.5 ms | Standard Deviation 0.4 |
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Latency | Baseline-Sural peak latency (ms) | 3.8 ms | Standard Deviation 0.5 |
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Latency | 24 Months-Peroneal distal motor latency (ms) | 4.3 ms | Standard Deviation 0.5 |
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Latency | Baseline-Tibial distal motor latency (ms) | 4.8 ms | Standard Deviation 0.6 |
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Latency | 24 Months-Tibial distal motor latency (ms) | 4.3 ms | Standard Deviation 0.7 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Latency | Baseline-Tibial distal motor latency (ms) | 4.9 ms | Standard Deviation 0.8 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Latency | 24 Months-Peroneal distal motor latency (ms) | 4.4 ms | Standard Deviation 0.7 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Latency | 24 Months-Tibial distal motor latency (ms) | 4.4 ms | Standard Deviation 0.8 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Latency | Baseline-Peroneal distal motor latency (ms) | 4.4 ms | Standard Deviation 0.6 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Latency | 24 Months-Sural peak latency (ms) | 3.5 ms | Standard Deviation 0.4 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Latency | Baseline-Sural peak latency (ms) | 3.7 ms | Standard Deviation 0.4 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Latency | Baseline-Sural peak latency (ms) | 3.6 ms | Standard Deviation 0.3 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Latency | Baseline-Peroneal distal motor latency (ms) | 4.4 ms | Standard Deviation 0.7 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Latency | Baseline-Tibial distal motor latency (ms) | 4.5 ms | Standard Deviation 0.6 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Latency | 24 Months-Peroneal distal motor latency (ms) | 4.2 ms | Standard Deviation 0.7 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Latency | 24 Months-Sural peak latency (ms) | 3.6 ms | Standard Deviation 0.6 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Latency | 24 Months-Tibial distal motor latency (ms) | 4.3 ms | Standard Deviation 0.9 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Latency | Baseline-Peroneal distal motor latency (ms) | 4.5 ms | Standard Deviation 1 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Latency | Baseline-Sural peak latency (ms) | 3.9 ms | Standard Deviation 0.4 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Latency | 24 Months-Tibial distal motor latency (ms) | 4.6 ms | Standard Deviation 1.1 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Latency | Baseline-Tibial distal motor latency (ms) | 4.7 ms | Standard Deviation 0.7 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Latency | 24 Months-Sural peak latency (ms) | 3.4 ms | Standard Deviation 0.5 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Latency | 24 Months-Peroneal distal motor latency (ms) | 4.2 ms | Standard Deviation 0.7 |
Comparison: Measure - Peroneal distal motor latency (ms)p-value: 0.8395% CI: [-0.4, 0.5]t-test, 2 sided
Comparison: Measure -Peroneal distal motor latency (ms)p-value: 0.3395% CI: [-0.62, 0.21]t-test, 2 sided
Comparison: Measure -Peroneal distal motor latency (ms)p-value: 0.7595% CI: [-0.36, 0.49]t-test, 2 sided
Comparison: Measure - Sural peak latency (ms)p-value: 0.4595% CI: [-0.49, 0.23]t-test, 2 sided
Comparison: Measure -Sural peak latency (ms)p-value: 0.1395% CI: [-0.57, 0.08]t-test, 2 sided
Comparison: Measure -Sural peak latency (ms)p-value: 0.0395% CI: [-0.79, -0.03]t-test, 2 sided
Comparison: Measure - Tibial distal motor latency (ms)p-value: 0.0595% CI: [-0.002, 1.01]t-test, 2 sided
Comparison: Measure - Tibial distal motor latency (ms)p-value: 0.0895% CI: [-0.07, 1.03]t-test, 2 sided
Comparison: Measure - Tibial distal motor latency (ms)p-value: 0.3895% CI: [-0.27, 0.7]t-test, 2 sided
Secondary
Nerve Conduction Study (NCS) - Motor Amplitude
Amplitude measures the height of electrical signal (waveform) in millivolts produced by the stimulated motor nerve. Was performed on peroneal, and tibial nerves. No response and abnormal values indicate neuropathy. * Peroneal: 0 - No response, \< 1.1 - Abnormal * Tibial: 0 - No response, \<1.1 - Abnormal
Time frame: Baseline and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Motor Amplitude | Baseline-Peroneal amplitude (mV) | 5.21 mV | Standard Deviation 2.39 |
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Motor Amplitude | 24 Months-Peroneal amplitude (mV) | 4.9 mV | Standard Deviation 2.11 |
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Motor Amplitude | Baseline-Tibial amplitude (mV) | 9.4 mV | Standard Deviation 3.59 |
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Motor Amplitude | 24 Months-Tibial amplitude (mV) | 9.65 mV | Standard Deviation 4.98 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Motor Amplitude | Baseline-Tibial amplitude (mV) | 9.16 mV | Standard Deviation 4.55 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Motor Amplitude | 24 Months-Peroneal amplitude (mV) | 6.23 mV | Standard Deviation 2.93 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Motor Amplitude | Baseline-Peroneal amplitude (mV) | 5.95 mV | Standard Deviation 3.05 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Motor Amplitude | 24 Months-Tibial amplitude (mV) | 9.28 mV | Standard Deviation 4.75 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Motor Amplitude | Baseline-Tibial amplitude (mV) | 8.06 mV | Standard Deviation 4.4 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Motor Amplitude | 24 Months-Peroneal amplitude (mV) | 4.93 mV | Standard Deviation 2.02 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Motor Amplitude | 24 Months-Tibial amplitude (mV) | 8.54 mV | Standard Deviation 4.02 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Motor Amplitude | Baseline-Peroneal amplitude (mV) | 5.18 mV | Standard Deviation 2.56 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Motor Amplitude | Baseline-Peroneal amplitude (mV) | 6.25 mV | Standard Deviation 4.13 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Motor Amplitude | Baseline-Tibial amplitude (mV) | 7.59 mV | Standard Deviation 4.66 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Motor Amplitude | 24 Months-Peroneal amplitude (mV) | 5.11 mV | Standard Deviation 4.04 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Motor Amplitude | 24 Months-Tibial amplitude (mV) | 8.04 mV | Standard Deviation 4.22 |
Comparison: Measure - Peroneal amplitude (mV)p-value: 0.48t-test, 2 sided
Comparison: Measure - Peroneal amplitude (mV)p-value: 0.31t-test, 2 sided
Comparison: Measure - Peroneal amplitude (mV)p-value: 0.23t-test, 2 sided
Comparison: Measure - Tibial amplitude (mV)p-value: 0.65t-test, 2 sided
Comparison: Measure - Tibial amplitude (mV)p-value: 0.69t-test, 2 sided
Comparison: Measure - Tibial amplitude (mV)p-value: 0.69t-test, 2 sided
Secondary
Nerve Conduction Study (NCS) - Sensory Amplitude
Amplitude measures the height of electrical signal (waveform) in microvolts produced by the stimulated sensory nerve. Was performed on sural nerve. No response and abnormal values indicate neuropathy. \* Sural: 0 - No response, \<4 - Abnormal
Time frame: Baseline and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Sensory Amplitude | 24 Months-Sural amplitude (µV) | 12.4 μV | Standard Deviation 6.1 |
| Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Sensory Amplitude | Baseline-Sural amplitude (µV) | 12.4 μV | Standard Deviation 5 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Sensory Amplitude | 24 Months-Sural amplitude (µV) | 14.2 μV | Standard Deviation 5.8 |
| Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Sensory Amplitude | Baseline-Sural amplitude (µV) | 10.8 μV | Standard Deviation 5.3 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Sensory Amplitude | Baseline-Sural amplitude (µV) | 10.6 μV | Standard Deviation 4.7 |
| No Bariatric Surgery/HIIT | Nerve Conduction Study (NCS) - Sensory Amplitude | 24 Months-Sural amplitude (µV) | 10.7 μV | Standard Deviation 5.7 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Sensory Amplitude | Baseline-Sural amplitude (µV) | 9.1 μV | Standard Deviation 5.3 |
| No Bariatric Surgery/Routine Exercise | Nerve Conduction Study (NCS) - Sensory Amplitude | 24 Months-Sural amplitude (µV) | 10.6 μV | Standard Deviation 6.7 |
Comparison: Measure - Sural amplitude (µV)p-value: 0.82t-test, 2 sided
Comparison: Measure - Sural amplitude (µV)p-value: 0.26t-test, 2 sided
Comparison: Measure - Sural amplitude (µV)p-value: 0.62t-test, 2 sided
Secondary
Neuropathy Quality of Life (NeuroQOL)
Neuropathy Quality of Life (NeuroQOL) evaluates symptoms and function in regard to quality of life over the past four weeks. Range 1-15, higher score indicates neuropathy having a greater impact on quality of life.
Time frame: Baseline, 3 months, 12 months, and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Neuropathy Quality of Life (NeuroQOL) | Baseline | 2.62 NeuroQOL Score | Standard Deviation 2.34 |
| Bariatric Surgery/HIIT | Neuropathy Quality of Life (NeuroQOL) | 3 Months | 2.49 NeuroQOL Score | Standard Deviation 2.37 |
| Bariatric Surgery/HIIT | Neuropathy Quality of Life (NeuroQOL) | 12 Months | 2.23 NeuroQOL Score | Standard Deviation 2.48 |
| Bariatric Surgery/HIIT | Neuropathy Quality of Life (NeuroQOL) | 24 Months | 3.07 NeuroQOL Score | Standard Deviation 3.02 |
| Bariatric Surgery/Routine Exercise | Neuropathy Quality of Life (NeuroQOL) | 3 Months | 1.62 NeuroQOL Score | Standard Deviation 0.5 |
| Bariatric Surgery/Routine Exercise | Neuropathy Quality of Life (NeuroQOL) | 12 Months | 1.62 NeuroQOL Score | Standard Deviation 0.43 |
| Bariatric Surgery/Routine Exercise | Neuropathy Quality of Life (NeuroQOL) | 24 Months | 1.86 NeuroQOL Score | Standard Deviation 0.86 |
| Bariatric Surgery/Routine Exercise | Neuropathy Quality of Life (NeuroQOL) | Baseline | 2.13 NeuroQOL Score | Standard Deviation 1.12 |
| No Bariatric Surgery/HIIT | Neuropathy Quality of Life (NeuroQOL) | 12 Months | 2.21 NeuroQOL Score | Standard Deviation 0.87 |
| No Bariatric Surgery/HIIT | Neuropathy Quality of Life (NeuroQOL) | 3 Months | 1.93 NeuroQOL Score | Standard Deviation 0.97 |
| No Bariatric Surgery/HIIT | Neuropathy Quality of Life (NeuroQOL) | 24 Months | 1.7 NeuroQOL Score | Standard Deviation 0.58 |
| No Bariatric Surgery/HIIT | Neuropathy Quality of Life (NeuroQOL) | Baseline | 2.1 NeuroQOL Score | Standard Deviation 0.94 |
| No Bariatric Surgery/Routine Exercise | Neuropathy Quality of Life (NeuroQOL) | 24 Months | 2.55 NeuroQOL Score | Standard Deviation 1.98 |
| No Bariatric Surgery/Routine Exercise | Neuropathy Quality of Life (NeuroQOL) | 3 Months | 2.7 NeuroQOL Score | Standard Deviation 1.5 |
| No Bariatric Surgery/Routine Exercise | Neuropathy Quality of Life (NeuroQOL) | Baseline | 2.71 NeuroQOL Score | Standard Deviation 1.98 |
| No Bariatric Surgery/Routine Exercise | Neuropathy Quality of Life (NeuroQOL) | 12 Months | 2.42 NeuroQOL Score | Standard Deviation 1.26 |
Comparison: NeuroQOL- overall QOLp-value: 0.8395% CI: [-0.53, 0.65]t-test, 2 sided
Comparison: NeuroQOL- overall QOLp-value: 0.9795% CI: [-0.76, 0.78]t-test, 2 sided
Comparison: NeuroQOL- overall QOLp-value: 0.7695% CI: [-0.73, 0.54]t-test, 2 sided
Secondary
Neurothesiometer
Neurothesiometer is placed on the bottom of the great toe, and slowly increased until participant reports they can feel the vibration. The greater the microns, the less feeling the participant has, suggestive of worse sensory function. Value \> 25 Microns is indicative of neuropathy. There is no known maximum range. Lower values indicate better sensory function.
Time frame: Baseline, 3 months, 12 months, and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Neurothesiometer | 24 Months | 13.6 Microns | Standard Deviation 14.2 |
| Bariatric Surgery/HIIT | Neurothesiometer | 3 Months | 9.7 Microns | Standard Deviation 11.3 |
| Bariatric Surgery/HIIT | Neurothesiometer | 12 Months | 12.1 Microns | Standard Deviation 12.8 |
| Bariatric Surgery/HIIT | Neurothesiometer | Baseline | 8.7 Microns | Standard Deviation 8.3 |
| Bariatric Surgery/Routine Exercise | Neurothesiometer | 3 Months | 8 Microns | Standard Deviation 5.6 |
| Bariatric Surgery/Routine Exercise | Neurothesiometer | Baseline | 10.2 Microns | Standard Deviation 9 |
| Bariatric Surgery/Routine Exercise | Neurothesiometer | 24 Months | 8 Microns | Standard Deviation 6.2 |
| Bariatric Surgery/Routine Exercise | Neurothesiometer | 12 Months | 9.9 Microns | Standard Deviation 15 |
| No Bariatric Surgery/HIIT | Neurothesiometer | Baseline | 21.1 Microns | Standard Deviation 47.4 |
| No Bariatric Surgery/HIIT | Neurothesiometer | 3 Months | 20.8 Microns | Standard Deviation 47.7 |
| No Bariatric Surgery/HIIT | Neurothesiometer | 24 Months | 12 Microns | Standard Deviation 11.3 |
| No Bariatric Surgery/HIIT | Neurothesiometer | 12 Months | 19.1 Microns | Standard Deviation 47.7 |
| No Bariatric Surgery/Routine Exercise | Neurothesiometer | Baseline | 20.2 Microns | Standard Deviation 34.9 |
| No Bariatric Surgery/Routine Exercise | Neurothesiometer | 12 Months | 23.3 Microns | Standard Deviation 48.3 |
| No Bariatric Surgery/Routine Exercise | Neurothesiometer | 3 Months | 15.4 Microns | Standard Deviation 27 |
| No Bariatric Surgery/Routine Exercise | Neurothesiometer | 24 Months | 21.7 Microns | Standard Deviation 39.5 |
p-value: 0.3695% CI: [-6.37, 2.36]t-test, 2 sided
p-value: <0.0195% CI: [1.31, 7.71]t-test, 2 sided
p-value: 0.395% CI: [-5.37, 16.63]t-test, 2 sided
Secondary
NIH Toolbox Cognitive Battery
NIH Toolbox Cognition Fluid (Range: 0-100) - Composite score derived as an average across five cognitive domains. It's a fully adjusted T-score comparing the participant to a nationally representative sample, stratified by age and other demographics. Individual domain scores are fully adjusted T score with range 0-100 and measures the following- * Inhibitory Control and Attention - executive function, attention . * Dimensional Change Card Sort - executive function * Picture Sequence Memory - episodic memory * List Sorting Working Memory - working memory * Pattern Comparison - processing speed A T-score of 50 represents the population mean. A score of 60 indicates that the participant is 1 SD above the national average for individuals with similar demographic characteristics Higher scores reflect better cognitive functionality. No set clinical threshold, scores above mean indicate above average cognition for a given age group.
Time frame: Baseline and at 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | Baseline Inhibitory Control and Attention Test | 42.6 T-score | Standard Deviation 6.8 |
| Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | Baseline Dimensional Change Card Sort Test | 51.6 T-score | Standard Deviation 12.9 |
| Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | Baseline Picture Sequence Memory Test | 56.2 T-score | Standard Deviation 11.8 |
| Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | Baseline List Sorting Working Memory Test | 54.8 T-score | Standard Deviation 10.1 |
| Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | Baseline Pattern Comparison Processing Speed Test | 48.9 T-score | Standard Deviation 13.1 |
| Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | Baseline Cognition Fluid Composite | 51.2 T-score | Standard Deviation 12.3 |
| Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | 24 Months Inhibitory Control and Attention Test | 42.9 T-score | Standard Deviation 9.3 |
| Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | 24 Months Dimensional Change Card Sort Test | 53.7 T-score | Standard Deviation 12.5 |
| Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | 24 Months Picture Sequence Memory Test | 55.9 T-score | Standard Deviation 10.8 |
| Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | 24 Months List Sorting Working Memory Test | 56.6 T-score | Standard Deviation 10.1 |
| Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | 24 Months Pattern Comparison Processing Speed Test | 52.7 T-score | Standard Deviation 13.8 |
| Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | 24 Months Cognition Fluid Composite | 53.5 T-score | Standard Deviation 12.2 |
| Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | Baseline Pattern Comparison Processing Speed Test | 49.4 T-score | Standard Deviation 12.2 |
| Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | 24 Months Picture Sequence Memory Test | 54.7 T-score | Standard Deviation 13 |
| Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | 24 Months Cognition Fluid Composite | 50.4 T-score | Standard Deviation 11.2 |
| Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | 24 Months Dimensional Change Card Sort Test | 53.7 T-score | Standard Deviation 13.5 |
| Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | Baseline Dimensional Change Card Sort Test | 54.6 T-score | Standard Deviation 11.5 |
| Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | 24 Months Pattern Comparison Processing Speed Test | 46.7 T-score | Standard Deviation 16.7 |
| Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | Baseline Inhibitory Control and Attention Test | 44 T-score | Standard Deviation 8.3 |
| Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | Baseline Cognition Fluid Composite | 51.6 T-score | Standard Deviation 11.8 |
| Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | Baseline Picture Sequence Memory Test | 55.8 T-score | Standard Deviation 12.2 |
| Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | 24 Months List Sorting Working Memory Test | 52.1 T-score | Standard Deviation 8.6 |
| Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | Baseline List Sorting Working Memory Test | 51.7 T-score | Standard Deviation 9.3 |
| Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | 24 Months Inhibitory Control and Attention Test | 44.3 T-score | Standard Deviation 7.6 |
| No Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | 24 Months Cognition Fluid Composite | 53.9 T-score | Standard Deviation 9.1 |
| No Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | 24 Months Pattern Comparison Processing Speed Test | 48.8 T-score | Standard Deviation 13.4 |
| No Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | Baseline Cognition Fluid Composite | 52.1 T-score | Standard Deviation 11.2 |
| No Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | Baseline Pattern Comparison Processing Speed Test | 51 T-score | Standard Deviation 15 |
| No Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | 24 Months Inhibitory Control and Attention Test | 44.2 T-score | Standard Deviation 8.2 |
| No Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | 24 Months Dimensional Change Card Sort Test | 56.7 T-score | Standard Deviation 11 |
| No Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | 24 Months Picture Sequence Memory Test | 58.7 T-score | Standard Deviation 10.8 |
| No Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | 24 Months List Sorting Working Memory Test | 54.4 T-score | Standard Deviation 7.5 |
| No Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | Baseline Inhibitory Control and Attention Test | 42.7 T-score | Standard Deviation 7.8 |
| No Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | Baseline Dimensional Change Card Sort Test | 54.5 T-score | Standard Deviation 13.2 |
| No Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | Baseline List Sorting Working Memory Test | 53.3 T-score | Standard Deviation 10.8 |
| No Bariatric Surgery/HIIT | NIH Toolbox Cognitive Battery | Baseline Picture Sequence Memory Test | 55.6 T-score | Standard Deviation 12 |
| No Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | Baseline Dimensional Change Card Sort Test | 51.8 T-score | Standard Deviation 12.3 |
| No Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | 24 Months Pattern Comparison Processing Speed Test | 47.3 T-score | Standard Deviation 15.7 |
| No Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | Baseline Picture Sequence Memory Test | 54.2 T-score | Standard Deviation 8.5 |
| No Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | Baseline Inhibitory Control and Attention Test | 43 T-score | Standard Deviation 8.9 |
| No Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | 24 Months List Sorting Working Memory Test | 50.7 T-score | Standard Deviation 11.4 |
| No Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | Baseline Pattern Comparison Processing Speed Test | 50.4 T-score | Standard Deviation 13.9 |
| No Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | 24 Months Dimensional Change Card Sort Test | 54.6 T-score | Standard Deviation 10.9 |
| No Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | 24 Months Inhibitory Control and Attention Test | 43.9 T-score | Standard Deviation 8.5 |
| No Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | Baseline List Sorting Working Memory Test | 50.3 T-score | Standard Deviation 8.2 |
| No Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | 24 Months Picture Sequence Memory Test | 56.3 T-score | Standard Deviation 10.8 |
| No Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | 24 Months Cognition Fluid Composite | 50.6 T-score | Standard Deviation 10.2 |
| No Bariatric Surgery/Routine Exercise | NIH Toolbox Cognitive Battery | Baseline Cognition Fluid Composite | 49.8 T-score | Standard Deviation 11.3 |
Comparison: Inhibitory Control and Attention Testp-value: 0.1695% CI: [-1.3, 7.58]t-test, 2 sided
Comparison: Inhibitory Control and Attention Testp-value: 0.3395% CI: [-2.05, 5.88]t-test, 2 sided
Comparison: Inhibitory Control and Attention Testp-value: 0.4995% CI: [-2.72, 5.59]t-test, 2 sided
Comparison: Dimensional Change Card Sort Testp-value: 0.3595% CI: [-3.48, 9.44]t-test, 2 sided
Comparison: Dimensional Change Card Sort Testp-value: 0.195% CI: [-3.48, 9.44]t-test, 2 sided
Comparison: Dimensional Change Card Sort Testp-value: 0.3295% CI: [-3.34, 9.82]t-test, 2 sided
Comparison: Picture Sequence Memory Testp-value: 0.4995% CI: [-4.57, 9.37]t-test, 2 sided
Comparison: Picture Sequence Memory Testp-value: 0.395% CI: [-3.03, 9.56]t-test, 2 sided
Comparison: Picture Sequence Memory Testp-value: 0.8695% CI: [-5.4, 6.38]t-test, 2 sided
Comparison: List Sorting Working Memory Testp-value: 0.8895% CI: [-5.39, 6.24]t-test, 2 sided
Comparison: List Sorting Working Memory Testp-value: 0.8395% CI: [-5.14, 6.31]t-test, 2 sided
Comparison: List Sorting Working Memory Testp-value: 0.8195% CI: [-6.02, 4.76]t-test, 2 sided
Comparison: Pattern Comparison Processing Speed Testp-value: 0.1295% CI: [-12.1, 1.57]t-test, 2 sided
Comparison: Pattern Comparison Processing Speed Testp-value: 0.6395% CI: [-9.53, 5.84]t-test, 2 sided
Comparison: Pattern Comparison Processing Speed Testp-value: 0.495% CI: [-9.8, 4.05]t-test, 2 sided
Comparison: Cognition Fluid Compositep-value: 0.6595% CI: [-3.63, 5.73]t-test, 2 sided
Comparison: Cognition Fluid Compositep-value: 0.2795% CI: [-2.17, 7.54]t-test, 2 sided
Comparison: Cognition Fluid Compositep-value: 0.995% CI: [-4.1, 4.65]t-test, 2 sided
Comparison: Cognition Fluid Compositep-value: 0.8595% CI: [-0.21, 0.17]Mixed Models Analysis
Comparison: Cognition Fluid Compositep-value: 0.2895% CI: [-0.29, 0.09]Mixed Models Analysis
Comparison: Cognition Fluid Compositep-value: 0.9995% CI: [-0.18, 0.19]Mixed Models Analysis
Secondary
Numerical Rating Scale for Pain
Participant reported pain scale with range 0-10, higher score indicates more pain.
Time frame: Baseline, 3 months, 12 months, 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Numerical Rating Scale for Pain | Baseline | 2.2 score on a scale | Standard Deviation 2.6 |
| Bariatric Surgery/HIIT | Numerical Rating Scale for Pain | 3 Months | 3.3 score on a scale | Standard Deviation 4.2 |
| Bariatric Surgery/HIIT | Numerical Rating Scale for Pain | 12 Months | 2.9 score on a scale | Standard Deviation 4 |
| Bariatric Surgery/HIIT | Numerical Rating Scale for Pain | 24 Months | 3.8 score on a scale | Standard Deviation 4 |
| Bariatric Surgery/Routine Exercise | Numerical Rating Scale for Pain | 3 Months | 2.7 score on a scale | Standard Deviation 3.7 |
| Bariatric Surgery/Routine Exercise | Numerical Rating Scale for Pain | 12 Months | 3.5 score on a scale | Standard Deviation 4.2 |
| Bariatric Surgery/Routine Exercise | Numerical Rating Scale for Pain | 24 Months | 4.7 score on a scale | Standard Deviation 4.7 |
| Bariatric Surgery/Routine Exercise | Numerical Rating Scale for Pain | Baseline | 2.7 score on a scale | Standard Deviation 3.4 |
| No Bariatric Surgery/HIIT | Numerical Rating Scale for Pain | 12 Months | 6.1 score on a scale | Standard Deviation 4.4 |
| No Bariatric Surgery/HIIT | Numerical Rating Scale for Pain | 3 Months | 4.2 score on a scale | Standard Deviation 4.2 |
| No Bariatric Surgery/HIIT | Numerical Rating Scale for Pain | 24 Months | 4.5 score on a scale | Standard Deviation 4.3 |
| No Bariatric Surgery/HIIT | Numerical Rating Scale for Pain | Baseline | 2.5 score on a scale | Standard Deviation 3.7 |
| No Bariatric Surgery/Routine Exercise | Numerical Rating Scale for Pain | 24 Months | 5 score on a scale | Standard Deviation 4.2 |
| No Bariatric Surgery/Routine Exercise | Numerical Rating Scale for Pain | 3 Months | 3.6 score on a scale | Standard Deviation 4.2 |
| No Bariatric Surgery/Routine Exercise | Numerical Rating Scale for Pain | Baseline | 3.8 score on a scale | Standard Deviation 4 |
| No Bariatric Surgery/Routine Exercise | Numerical Rating Scale for Pain | 12 Months | 3.8 score on a scale | Standard Deviation 4.4 |
p-value: 0.62t-test, 2 sided
p-value: 0.92t-test, 2 sided
p-value: 0.9t-test, 2 sided
p-value: 0.4695% CI: [-0.06, 0.03]Mixed Models Analysis
p-value: 0.4795% CI: [-0.06, 0.03]Mixed Models Analysis
p-value: 0.9195% CI: [-0.04, 0.05]Mixed Models Analysis
Secondary
Participants With Probable Polyneuropathy as Defined by the Toronto Definition of Probable Neuropathy
Toronto definition of probable neuropathy is having at least 2 out of 3 of the following: abnormal sensory examination, reflexes, and patient-reported symptoms. Data is reported as number of participants who, under the Toronto definition, were identified as having probable polyneuropathy.
Time frame: 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bariatric Surgery/HIIT | Participants With Probable Polyneuropathy as Defined by the Toronto Definition of Probable Neuropathy | Baseline | 6 participants with probable neuropathy |
| Bariatric Surgery/HIIT | Participants With Probable Polyneuropathy as Defined by the Toronto Definition of Probable Neuropathy | 24 Months | 9 participants with probable neuropathy |
| Bariatric Surgery/Routine Exercise | Participants With Probable Polyneuropathy as Defined by the Toronto Definition of Probable Neuropathy | 24 Months | 7 participants with probable neuropathy |
| Bariatric Surgery/Routine Exercise | Participants With Probable Polyneuropathy as Defined by the Toronto Definition of Probable Neuropathy | Baseline | 5 participants with probable neuropathy |
| No Bariatric Surgery/HIIT | Participants With Probable Polyneuropathy as Defined by the Toronto Definition of Probable Neuropathy | Baseline | 9 participants with probable neuropathy |
| No Bariatric Surgery/HIIT | Participants With Probable Polyneuropathy as Defined by the Toronto Definition of Probable Neuropathy | 24 Months | 7 participants with probable neuropathy |
| No Bariatric Surgery/Routine Exercise | Participants With Probable Polyneuropathy as Defined by the Toronto Definition of Probable Neuropathy | Baseline | 11 participants with probable neuropathy |
| No Bariatric Surgery/Routine Exercise | Participants With Probable Polyneuropathy as Defined by the Toronto Definition of Probable Neuropathy | 24 Months | 9 participants with probable neuropathy |
Comparison: Wilcoxon signed rank test was used to compare within-participant change between baseline and 2 year for each treatment groupp-value: 0.07Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon signed rank test was used to compare within-participant change between baseline and 2 year for each treatment groupp-value: 0.34Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon signed rank test was used to compare within-participant change between baseline and 2 year for each treatment groupp-value: 0.42Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon signed rank test was used to compare within-participant change between baseline and 2 year for each treatment groupp-value: 0.77Wilcoxon (Mann-Whitney)
Secondary
Retinal Fundus Photography
As assessed by fundus photographs, participants were identified as either having retinopathy or not having retinopathy. Data is shown as number of people with retinopathy at a particular study visit.
Time frame: Baseline, 3 month, 12 months and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bariatric Surgery/HIIT | Retinal Fundus Photography | 12 Months | 0 Participants |
| Bariatric Surgery/HIIT | Retinal Fundus Photography | 24 Months | 0 Participants |
| Bariatric Surgery/HIIT | Retinal Fundus Photography | Baseline | 0 Participants |
| Bariatric Surgery/HIIT | Retinal Fundus Photography | 3 Months | 0 Participants |
| Bariatric Surgery/Routine Exercise | Retinal Fundus Photography | 12 Months | 0 Participants |
| Bariatric Surgery/Routine Exercise | Retinal Fundus Photography | 3 Months | 0 Participants |
| Bariatric Surgery/Routine Exercise | Retinal Fundus Photography | Baseline | 1 Participants |
| Bariatric Surgery/Routine Exercise | Retinal Fundus Photography | 24 Months | 0 Participants |
| No Bariatric Surgery/HIIT | Retinal Fundus Photography | 12 Months | 0 Participants |
| No Bariatric Surgery/HIIT | Retinal Fundus Photography | Baseline | 1 Participants |
| No Bariatric Surgery/HIIT | Retinal Fundus Photography | 3 Months | 0 Participants |
| No Bariatric Surgery/HIIT | Retinal Fundus Photography | 24 Months | 0 Participants |
| No Bariatric Surgery/Routine Exercise | Retinal Fundus Photography | Baseline | 1 Participants |
| No Bariatric Surgery/Routine Exercise | Retinal Fundus Photography | 12 Months | 0 Participants |
| No Bariatric Surgery/Routine Exercise | Retinal Fundus Photography | 24 Months | 0 Participants |
| No Bariatric Surgery/Routine Exercise | Retinal Fundus Photography | 3 Months | 0 Participants |
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 0.44Fisher Exact
Secondary
Rey Auditory Verbal Learning Test
Used to evaluate verbal learning and memory using a list of 15 unrelated words presented to the participant over repeat trial. Includes 3 independent scales: * Auditory Learning (Total recall) - Measures memory and learning ability. Raw score range (0- 75) * Delayed Recall - Measures long term memory retention. Raw score range (0-15) * Recognition - Measures ability to recognize previously learned information. Raw score range (0-15). * Raw scores were converted to age-standardized Z-scores using 10-year age bands (e.g., 20-29, 30-39, 40-49, etc.), with a mean of 0 and standard deviation of 1. * A Z-score of 0 represents the population mean * For each scale, scores above 0 are better. Standard deviations above the mean indicates a better learning and memory ability for a given age group. No set clinical threshold, scores above mean indicate above average cognition for a given age group.
Time frame: Baseline and at 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Rey Auditory Verbal Learning Test | Baseline Recognition | 0.7 Z-score | Standard Deviation 0.8 |
| Bariatric Surgery/HIIT | Rey Auditory Verbal Learning Test | 24 Months Auditory Learning | -0.2 Z-score | Standard Deviation 1.3 |
| Bariatric Surgery/HIIT | Rey Auditory Verbal Learning Test | Baseline Auditory Learning | 0.1 Z-score | Standard Deviation 1.2 |
| Bariatric Surgery/HIIT | Rey Auditory Verbal Learning Test | Baseline Delayed Recall | 0 Z-score | Standard Deviation 1.1 |
| Bariatric Surgery/HIIT | Rey Auditory Verbal Learning Test | 24 Months Delayed Recall | -0.4 Z-score | Standard Deviation 1 |
| Bariatric Surgery/HIIT | Rey Auditory Verbal Learning Test | 24 Months Recognition | 0.6 Z-score | Standard Deviation 1.2 |
| Bariatric Surgery/Routine Exercise | Rey Auditory Verbal Learning Test | Baseline Delayed Recall | -0.2 Z-score | Standard Deviation 1.1 |
| Bariatric Surgery/Routine Exercise | Rey Auditory Verbal Learning Test | Baseline Recognition | 0.6 Z-score | Standard Deviation 0.8 |
| Bariatric Surgery/Routine Exercise | Rey Auditory Verbal Learning Test | 24 Months Recognition | 0.9 Z-score | Standard Deviation 0.8 |
| Bariatric Surgery/Routine Exercise | Rey Auditory Verbal Learning Test | 24 Months Delayed Recall | -0.1 Z-score | Standard Deviation 1 |
| Bariatric Surgery/Routine Exercise | Rey Auditory Verbal Learning Test | Baseline Auditory Learning | 0.3 Z-score | Standard Deviation 1.2 |
| Bariatric Surgery/Routine Exercise | Rey Auditory Verbal Learning Test | 24 Months Auditory Learning | 0.2 Z-score | Standard Deviation 1.2 |
| No Bariatric Surgery/HIIT | Rey Auditory Verbal Learning Test | Baseline Auditory Learning | 0.4 Z-score | Standard Deviation 0.8 |
| No Bariatric Surgery/HIIT | Rey Auditory Verbal Learning Test | Baseline Delayed Recall | 0.1 Z-score | Standard Deviation 0.9 |
| No Bariatric Surgery/HIIT | Rey Auditory Verbal Learning Test | 24 Months Auditory Learning | 0.4 Z-score | Standard Deviation 1 |
| No Bariatric Surgery/HIIT | Rey Auditory Verbal Learning Test | Baseline Recognition | 0.7 Z-score | Standard Deviation 1.2 |
| No Bariatric Surgery/HIIT | Rey Auditory Verbal Learning Test | 24 Months Delayed Recall | 0.2 Z-score | Standard Deviation 0.9 |
| No Bariatric Surgery/HIIT | Rey Auditory Verbal Learning Test | 24 Months Recognition | 0.8 Z-score | Standard Deviation 1.2 |
| No Bariatric Surgery/Routine Exercise | Rey Auditory Verbal Learning Test | 24 Months Auditory Learning | 0 Z-score | Standard Deviation 1.1 |
| No Bariatric Surgery/Routine Exercise | Rey Auditory Verbal Learning Test | Baseline Auditory Learning | 0.4 Z-score | Standard Deviation 1 |
| No Bariatric Surgery/Routine Exercise | Rey Auditory Verbal Learning Test | 24 Months Recognition | 0 Z-score | Standard Deviation 1 |
| No Bariatric Surgery/Routine Exercise | Rey Auditory Verbal Learning Test | 24 Months Delayed Recall | -0.1 Z-score | Standard Deviation 1.1 |
| No Bariatric Surgery/Routine Exercise | Rey Auditory Verbal Learning Test | Baseline Recognition | 0.7 Z-score | Standard Deviation 0.9 |
| No Bariatric Surgery/Routine Exercise | Rey Auditory Verbal Learning Test | Baseline Delayed Recall | -0.1 Z-score | Standard Deviation 1 |
Comparison: Auditory Learningp-value: 0.5795% CI: [-0.87, 0.49]t-test, 2 sided
Comparison: Auditory Learningp-value: 0.3395% CI: [-0.81, 0.28]t-test, 2 sided
Comparison: Auditory Learningp-value: 0.2295% CI: [-1, 0.23]t-test, 2 sided
Comparison: Delayed Recallp-value: 0.2795% CI: [-0.23, 0.81]t-test, 2 sided
Comparison: Delayed Recallp-value: 0.5495% CI: [-0.69, 0.37]t-test, 2 sided
Comparison: Delayed Recallp-value: 0.9395% CI: [-0.57, 0.53]t-test, 2 sided
Comparison: Recognitionp-value: 0.6495% CI: [-0.46, 0.74]t-test, 2 sided
Comparison: Recognitionp-value: 0.3795% CI: [-0.7, 0.27]t-test, 2 sided
Comparison: Recognitionp-value: 0.8895% CI: [-0.59, 0.69]t-test, 2 sided
Secondary
Short Form McGill Pain Questionnaire
Sum of the sensory score (0-30) and affective score (0-15) for a total score of 0-45. A higher score represents greater pain present.
Time frame: Baseline, 3 months, 12 months, 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Short Form McGill Pain Questionnaire | Baseline | 3.7 score on a scale | Standard Deviation 4.4 |
| Bariatric Surgery/HIIT | Short Form McGill Pain Questionnaire | 24 Months | 5.2 score on a scale | Standard Deviation 6.6 |
| Bariatric Surgery/HIIT | Short Form McGill Pain Questionnaire | 12 Months | 3.3 score on a scale | Standard Deviation 8.5 |
| Bariatric Surgery/HIIT | Short Form McGill Pain Questionnaire | 3 Months | 3.8 score on a scale | Standard Deviation 7.7 |
| Bariatric Surgery/Routine Exercise | Short Form McGill Pain Questionnaire | 3 Months | 2.1 score on a scale | Standard Deviation 3.6 |
| Bariatric Surgery/Routine Exercise | Short Form McGill Pain Questionnaire | Baseline | 3.1 score on a scale | Standard Deviation 4.4 |
| Bariatric Surgery/Routine Exercise | Short Form McGill Pain Questionnaire | 12 Months | 2.3 score on a scale | Standard Deviation 3.4 |
| Bariatric Surgery/Routine Exercise | Short Form McGill Pain Questionnaire | 24 Months | 2.5 score on a scale | Standard Deviation 4.5 |
| No Bariatric Surgery/HIIT | Short Form McGill Pain Questionnaire | Baseline | 2.7 score on a scale | Standard Deviation 4.1 |
| No Bariatric Surgery/HIIT | Short Form McGill Pain Questionnaire | 24 Months | 2.1 score on a scale | Standard Deviation 2.6 |
| No Bariatric Surgery/HIIT | Short Form McGill Pain Questionnaire | 3 Months | 2.6 score on a scale | Standard Deviation 4.2 |
| No Bariatric Surgery/HIIT | Short Form McGill Pain Questionnaire | 12 Months | 2.4 score on a scale | Standard Deviation 2.8 |
| No Bariatric Surgery/Routine Exercise | Short Form McGill Pain Questionnaire | Baseline | 3.5 score on a scale | Standard Deviation 5.5 |
| No Bariatric Surgery/Routine Exercise | Short Form McGill Pain Questionnaire | 24 Months | 2.2 score on a scale | Standard Deviation 3.8 |
| No Bariatric Surgery/Routine Exercise | Short Form McGill Pain Questionnaire | 3 Months | 3.5 score on a scale | Standard Deviation 6 |
| No Bariatric Surgery/Routine Exercise | Short Form McGill Pain Questionnaire | 12 Months | 2.6 score on a scale | Standard Deviation 4.5 |
Comparison: Mcgill Total Scorep-value: 0.0995% CI: [-5.66, 0.44]t-test, 2 sided
Comparison: Mcgill Total Scorep-value: 0.5695% CI: [-4.36, 2.41]t-test, 2 sided
Comparison: Mcgill Total Scorep-value: 0.2195% CI: [-4.5, 1.05]t-test, 2 sided
Secondary
Survey of Autonomic Symptoms (SAS)
SAS evaluates the presence and magnitude of autonomic symptoms. Total impact score ranges from 0-60 (or up to 55 for participants to whom certain criteria did not apply). Higher score indicates worse autonomic neuropathy
Time frame: Baseline, 3 month, 12 months and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Survey of Autonomic Symptoms (SAS) | 12 Months | 5.3 score on a scale | Standard Deviation 7.2 |
| Bariatric Surgery/HIIT | Survey of Autonomic Symptoms (SAS) | 24 Months | 5.3 score on a scale | Standard Deviation 7.1 |
| Bariatric Surgery/HIIT | Survey of Autonomic Symptoms (SAS) | 3 Months | 8.2 score on a scale | Standard Deviation 8.3 |
| Bariatric Surgery/HIIT | Survey of Autonomic Symptoms (SAS) | Baseline | 4.7 score on a scale | Standard Deviation 4.1 |
| Bariatric Surgery/Routine Exercise | Survey of Autonomic Symptoms (SAS) | 3 Months | 4.9 score on a scale | Standard Deviation 4.2 |
| Bariatric Surgery/Routine Exercise | Survey of Autonomic Symptoms (SAS) | 12 Months | 5.1 score on a scale | Standard Deviation 4.1 |
| Bariatric Surgery/Routine Exercise | Survey of Autonomic Symptoms (SAS) | 24 Months | 8.4 score on a scale | Standard Deviation 4 |
| Bariatric Surgery/Routine Exercise | Survey of Autonomic Symptoms (SAS) | Baseline | 5 score on a scale | Standard Deviation 4.3 |
| No Bariatric Surgery/HIIT | Survey of Autonomic Symptoms (SAS) | 3 Months | 3.4 score on a scale | Standard Deviation 3.8 |
| No Bariatric Surgery/HIIT | Survey of Autonomic Symptoms (SAS) | 12 Months | 4.5 score on a scale | Standard Deviation 3.6 |
| No Bariatric Surgery/HIIT | Survey of Autonomic Symptoms (SAS) | Baseline | 5.1 score on a scale | Standard Deviation 4.7 |
| No Bariatric Surgery/HIIT | Survey of Autonomic Symptoms (SAS) | 24 Months | 5.3 score on a scale | Standard Deviation 5.3 |
| No Bariatric Surgery/Routine Exercise | Survey of Autonomic Symptoms (SAS) | Baseline | 5.1 score on a scale | Standard Deviation 5.1 |
| No Bariatric Surgery/Routine Exercise | Survey of Autonomic Symptoms (SAS) | 12 Months | 6.2 score on a scale | Standard Deviation 7.3 |
| No Bariatric Surgery/Routine Exercise | Survey of Autonomic Symptoms (SAS) | 24 Months | 6.2 score on a scale | Standard Deviation 5.7 |
| No Bariatric Surgery/Routine Exercise | Survey of Autonomic Symptoms (SAS) | 3 Months | 4.8 score on a scale | Standard Deviation 4.3 |
p-value: 0.8495% CI: [-6.68, 5.59]t-test, 2 sided
p-value: 0.4895% CI: [-7.57, 12.97]t-test, 2 sided
p-value: 0.6495% CI: [-4.94, 3.18]t-test, 2 sided
Secondary
Utah Early Neuropathy Score (UENS)
UENS is a composite score with five sections measuring multiple clinical measures of nerve injury. Sections are scored separately for each side (Right vs Left), and the total score is the sum across everything. Range: 0-42, higher score represents more severe polyneuropathy.
Time frame: Baseline, 3 month, 12 months and 24 months
Population: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery/HIIT | Utah Early Neuropathy Score (UENS) | 12 Months UENS Total Score | 3.9 score on a scale | Standard Deviation 4.9 |
| Bariatric Surgery/HIIT | Utah Early Neuropathy Score (UENS) | 3 Months UENS Total Score | 1.7 score on a scale | Standard Deviation 2.8 |
| Bariatric Surgery/HIIT | Utah Early Neuropathy Score (UENS) | Baseline UENS Total Score | 2.4 score on a scale | Standard Deviation 4.1 |
| Bariatric Surgery/HIIT | Utah Early Neuropathy Score (UENS) | 24 Months UENS Total Score | 2.8 score on a scale | Standard Deviation 3.7 |
| Bariatric Surgery/Routine Exercise | Utah Early Neuropathy Score (UENS) | 3 Months UENS Total Score | 1.8 score on a scale | Standard Deviation 3.5 |
| Bariatric Surgery/Routine Exercise | Utah Early Neuropathy Score (UENS) | Baseline UENS Total Score | 1.6 score on a scale | Standard Deviation 2.6 |
| Bariatric Surgery/Routine Exercise | Utah Early Neuropathy Score (UENS) | 12 Months UENS Total Score | 2.8 score on a scale | Standard Deviation 3.8 |
| Bariatric Surgery/Routine Exercise | Utah Early Neuropathy Score (UENS) | 24 Months UENS Total Score | 2.5 score on a scale | Standard Deviation 3.6 |
| No Bariatric Surgery/HIIT | Utah Early Neuropathy Score (UENS) | Baseline UENS Total Score | 2.4 score on a scale | Standard Deviation 3.7 |
| No Bariatric Surgery/HIIT | Utah Early Neuropathy Score (UENS) | 24 Months UENS Total Score | 2.9 score on a scale | Standard Deviation 2.3 |
| No Bariatric Surgery/HIIT | Utah Early Neuropathy Score (UENS) | 12 Months UENS Total Score | 3.2 score on a scale | Standard Deviation 5.2 |
| No Bariatric Surgery/HIIT | Utah Early Neuropathy Score (UENS) | 3 Months UENS Total Score | 2.9 score on a scale | Standard Deviation 5.2 |
| No Bariatric Surgery/Routine Exercise | Utah Early Neuropathy Score (UENS) | 3 Months UENS Total Score | 3 score on a scale | Standard Deviation 4.3 |
| No Bariatric Surgery/Routine Exercise | Utah Early Neuropathy Score (UENS) | 24 Months UENS Total Score | 3.8 score on a scale | Standard Deviation 4.8 |
| No Bariatric Surgery/Routine Exercise | Utah Early Neuropathy Score (UENS) | Baseline UENS Total Score | 3.5 score on a scale | Standard Deviation 4.6 |
| No Bariatric Surgery/Routine Exercise | Utah Early Neuropathy Score (UENS) | 12 Months UENS Total Score | 4.8 score on a scale | Standard Deviation 6.3 |
Comparison: Total Scorep-value: 0.44-1.2% CI: [-1.2, 2.67]t-test, 2 sided
Comparison: Total Scorep-value: 0.9795% CI: [-2.16, 2.1]t-test, 2 sided
Comparison: Total Scorep-value: 0.7195% CI: [-1.78, 2.58]t-test, 2 sided
Comparison: Total Scorep-value: 0.9995% CI: [0.98, 1.02]Mixed Models Analysis
Comparison: Total Scorep-value: 0.8895% CI: [0.98, 1.02]Mixed Models Analysis
Comparison: Total Scorep-value: 0.0995% CI: [0.97, 1]Mixed Models Analysis