Diabetes, Weightloss
Conditions
Keywords
Weightloss and brain function, Effects of bariatric surgery on brain function, Reduced glucose insulin changes and brain function
Brief summary
This study is being done to learn about the changes that weight loss causes on brain function, memory and thinking ability in adults. The study does NOT cover any costs associated with bariatric surgery.
Detailed description
There will be two groups of people studied: One group has chosen (independently of this research study) to have weight loss surgery to help them lose weight. Another group will not choose to have any weight loss surgery. All research participants will be tested on thinking and memory processes at the start of the study, after 12 weeks, and again at 18 months. They will have an MRI Brain Scan at those same times also to look at changes in the structure and function of the brain tissue. Blood tests will be done to measure the sugar levels in the blood, and other proteins that may act as markers for disease.
Interventions
PROCEDUREBariatric Surgery Candidates
Participants who are intending to have bariatric surgery for weight loss
OTHERNon surgical/Community volunteers
Healthy adults with body mass index \>35 who will not undergo bariatric surgery for weight loss
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Florida
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index \>35 * Diabetes or no diabetes * Compatible with MRI Scanning * Willing to give a small blood sample on 3 occasions * Capable of providing informed consent
Exclusion criteria
* Prior neurological disorder * Mini Mental Status Exam score * Major psychiatric disturbance (schizophrenia, chronic intractable depression, * Coronary revascularization, peripheral vascular disease * Severe cardio vascular disease history * Unstable medical conditions (cancer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in BOLD fMRI Signal | Change from baseline at 18 months | Brain activation changes will change in the frontal cortex and hippocampus. * z-score is a transformation of the Pearson's (r) correlation coefficient of the BOLD timeseries between two brain regions * a value of \< 0 suggests a weakening of the connections between brain areas; and a value of \> 0 suggests a strengthening of the connections between brain areas * A value of r=0 indicates that two brain regions were functionally disconnected |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bariatric Surgery Candidates Participants who are intending to have bariatric surgery for weight loss at local surgical centers or UFHEALTH & Shands Hospital.
Bariatric Surgery Candidates: Participants who are intending to have bariatric surgery for weight loss | 150 |
| Non Surgical/Community Volunteers Healthy adults with body mass index \>35 who will not undergo bariatric surgery for weight loss
Non surgical/Community volunteers: Healthy adults with body mass index \>35 who will not undergo bariatric surgery for weight loss | 47 |
| Total | 197 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 12 | 3 |
| Overall Study | Death | 2 | 0 |
| Overall Study | Lost to Follow-up | 24 | 9 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 18 | 4 |
| Overall Study | Withdrawal by Subject | 18 | 1 |
Baseline characteristics
| Characteristic | Bariatric Surgery Candidates | Non Surgical/Community Volunteers | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 5 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 143 Participants | 42 Participants | 185 Participants |
| Age, Continuous | 42.54 years STANDARD_DEVIATION 11.51 | 52.29 years STANDARD_DEVIATION 12.51 | 44.86 years STANDARD_DEVIATION 12.44 |
| Age, Customized Mean by intervention condition | 42.54 years STANDARD_DEVIATION 11.51 | 52.29 years STANDARD_DEVIATION 12.51 | 44.86 years STANDARD_DEVIATION 12.44 |
| Age of study participants | 42.54 years STANDARD_DEVIATION 11.51 | 52.29 years STANDARD_DEVIATION 12.51 | 44.86 years STANDARD_DEVIATION 12.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 4 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 138 Participants | 43 Participants | 181 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants | 14 Participants | 49 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 2 Participants | 17 Participants |
| Race (NIH/OMB) White | 100 Participants | 31 Participants | 131 Participants |
| Region of Enrollment United States | 150 participants | 47 participants | 197 participants |
| Sex: Female, Male Female | 118 Participants | 32 Participants | 150 Participants |
| Sex: Female, Male Male | 32 Participants | 15 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 150 | 0 / 47 |
| other Total, other adverse events | 11 / 150 | 3 / 47 |
| serious Total, serious adverse events | 5 / 150 | 0 / 47 |
Outcome results
Primary
Change in BOLD fMRI Signal
Brain activation changes will change in the frontal cortex and hippocampus. * z-score is a transformation of the Pearson's (r) correlation coefficient of the BOLD timeseries between two brain regions * a value of \< 0 suggests a weakening of the connections between brain areas; and a value of \> 0 suggests a strengthening of the connections between brain areas * A value of r=0 indicates that two brain regions were functionally disconnected
Time frame: Change from baseline at 18 months
Population: 37 individuals completed pre-surgery MRI at baseline and 18-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Baseline - Seed (R Hippocampus) to cluster (MNI -44 -26 46) | 0.10 Connectivity Fisher-z transformation | Standard Deviation 0.1 |
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Follow-up - Seed (R Hippocampus) to cluster (MNI -44 -26 46) | 0.18 Connectivity Fisher-z transformation | Standard Deviation 0.13 |
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Follow-up - Seed (L Hippocampus) to cluster (MNI 16, -24, 56) | 0.16 Connectivity Fisher-z transformation | Standard Deviation 0.14 |
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Baseline - Seed (R Frontal Pole) to cluster (MNI 60, -26, 24) | 0.07 Connectivity Fisher-z transformation | Standard Deviation 0.09 |
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Baseline - Seed (R Inferior Frontal Gyrus) to cluster (MNI -66, -24, -20) | 0.12 Connectivity Fisher-z transformation | Standard Deviation 0.09 |
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Baseline - Seed (R Inferior Frontal Gyrus) to cluster (MNI 40, -22, 52) | 0.22 Connectivity Fisher-z transformation | Standard Deviation 0.12 |
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Follow-up - Seed (R Inferior Frontal Gyrus) to cluster (MNI 40, -22, 52) | 0.34 Connectivity Fisher-z transformation | Standard Deviation 0.1 |
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Baseline - Seed (R Inferior Frontal Gyrus) to cluster (MNI 02, -38, 66) | 0.14 Connectivity Fisher-z transformation | Standard Deviation 0.12 |
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Follow-up - Seed (R Inferior Frontal Gyrus) to cluster (MNI 02, -38, 66) | 0.25 Connectivity Fisher-z transformation | Standard Deviation 0.13 |
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Baseline - Seed (L Inferior Frontal Gyrus) to cluster (MNI 32, 14, -16) | 0.12 Connectivity Fisher-z transformation | Standard Deviation 0.11 |
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Baseline - Seed (L Hippocampus) to cluster (MNI 16, -24, 56) | 0.09 Connectivity Fisher-z transformation | Standard Deviation 0.09 |
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Follow-up - Seed (R Frontal Pole) to cluster (MNI 60, -26, 24) | 0.21 Connectivity Fisher-z transformation | Standard Deviation 0.16 |
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Baseline - Seed (L Frontal Pole) to cluster (MNI 60, 08, -30) | 0.05 Connectivity Fisher-z transformation | Standard Deviation 0.1 |
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Follow-up - Seed (L Frontal Pole) to cluster (MNI 60, 08, -30) | 0.16 Connectivity Fisher-z transformation | Standard Deviation 0.11 |
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Follow-up - Seed (R Inferior Frontal Gyrus) to cluster (MNI -66, -24, -20) | 0.24 Connectivity Fisher-z transformation | Standard Deviation 0.09 |
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Follow-up - Seed (L Inferior Frontal Gyrus) to cluster (MNI 32, 14, -16) | 0.22 Connectivity Fisher-z transformation | Standard Deviation 0.09 |
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Baseline - Seed (Anterior Cingulate) to cluster (MNI 60, -06, -04) | 0.07 Connectivity Fisher-z transformation | Standard Deviation 0.1 |
| Bariatric Surgery Candidates | Change in BOLD fMRI Signal | Follow-up - Seed (Anterior Cingulate) to cluster (MNI 60, -06, -04) | 0.17 Connectivity Fisher-z transformation | Standard Deviation 0.1 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Follow-up - Seed (L Frontal Pole) to cluster (MNI 60, 08, -30) | 0.00 Connectivity Fisher-z transformation | Standard Deviation 0.1 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Baseline - Seed (R Hippocampus) to cluster (MNI -44 -26 46) | 0.08 Connectivity Fisher-z transformation | Standard Deviation 0.09 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Baseline - Seed (L Inferior Frontal Gyrus) to cluster (MNI 32, 14, -16) | 0.11 Connectivity Fisher-z transformation | Standard Deviation 0.09 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Follow-up - Seed (R Hippocampus) to cluster (MNI -44 -26 46) | -0.01 Connectivity Fisher-z transformation | Standard Deviation 0.13 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Follow-up - Seed (Anterior Cingulate) to cluster (MNI 60, -06, -04) | 0.00 Connectivity Fisher-z transformation | Standard Deviation 0.13 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Follow-up - Seed (L Hippocampus) to cluster (MNI 16, -24, 56) | -0.03 Connectivity Fisher-z transformation | Standard Deviation 0.14 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Baseline - Seed (L Hippocampus) to cluster (MNI 16, -24, 56) | 0.09 Connectivity Fisher-z transformation | Standard Deviation 0.1 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Baseline - Seed (R Frontal Pole) to cluster (MNI 60, -26, 24) | 0.10 Connectivity Fisher-z transformation | Standard Deviation 0.09 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Follow-up - Seed (R Inferior Frontal Gyrus) to cluster (MNI -66, -24, -20) | 0.09 Connectivity Fisher-z transformation | Standard Deviation 0.1 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Baseline - Seed (R Inferior Frontal Gyrus) to cluster (MNI -66, -24, -20) | 0.15 Connectivity Fisher-z transformation | Standard Deviation 0.08 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Follow-up - Seed (R Frontal Pole) to cluster (MNI 60, -26, 24) | 0.03 Connectivity Fisher-z transformation | Standard Deviation 0.14 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Baseline - Seed (R Inferior Frontal Gyrus) to cluster (MNI 40, -22, 52) | 0.20 Connectivity Fisher-z transformation | Standard Deviation 0.1 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Baseline - Seed (Anterior Cingulate) to cluster (MNI 60, -06, -04) | 0.10 Connectivity Fisher-z transformation | Standard Deviation 0.1 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Follow-up - Seed (R Inferior Frontal Gyrus) to cluster (MNI 40, -22, 52) | 0.14 Connectivity Fisher-z transformation | Standard Deviation 0.12 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Baseline - Seed (L Frontal Pole) to cluster (MNI 60, 08, -30) | 0.10 Connectivity Fisher-z transformation | Standard Deviation 0.07 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Baseline - Seed (R Inferior Frontal Gyrus) to cluster (MNI 02, -38, 66) | 0.12 Connectivity Fisher-z transformation | Standard Deviation 0.11 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Follow-up - Seed (L Inferior Frontal Gyrus) to cluster (MNI 32, 14, -16) | 0.01 Connectivity Fisher-z transformation | Standard Deviation 0.1 |
| Non Surgical/Community Volunteers | Change in BOLD fMRI Signal | Follow-up - Seed (R Inferior Frontal Gyrus) to cluster (MNI 02, -38, 66) | 0.06 Connectivity Fisher-z transformation | Standard Deviation 0.12 |
Comparison: Analysis of variance comparing change scores from 18 months post-surgery relative to pre-surgical baseline were performed. Change in the surgical group was compared to change for the non-surgical controls. The dependent measures were connectivity strengths seeding from the hippocampus and left dorsal lateral pre-frontal cortex to other cortical areas.p-value: <0.012x2 Factorial ANOVA in CONN