Gastroparesis With Diabetes Mellitus
Conditions
Brief summary
The device being studied, the Transcutaneous Electrical Accustimulator (TEA), will deliver weak electrical current at two specific points, one at the leg and the other at the arm at settings known to improve symptoms involving the digestive system. The study team would like to test if the device will impact the gastrointestinal (GI) symptoms and gastric motility in study participants with gastroparesis.
Detailed description
This study aims to assess if the device will impact the (GI) symptoms and gastric motility in study participants with gastroparesis. This will be done over a 12 week period during which each participant will undergo two visits. There will be two total visits that each follow the same schedule. During the first visit, subjects will undergo a 3-in-1 gastric functional test which is a non-invasive method to assess the gastric motility and visceral pain. This test will entail an EGG, ECG, and water satiety drink test for gastric accommodation. Following the 3-in-1 gastric functional test, subjects will be randomized and trained on how to use the study device. Half of the patients will be assigned to the sham group and half will be assigned to the treatment group. Each group will undergo 8 weeks of treatment or 8 weeks of sham stimulation and will receive weekly calls from the study team to check for adverse events and study compliance. Following the first 8 week period, subjects will return to the study site to undergo visit two. This will follow the same format as visit 1. At this time, subjects will become unblinded. Those who received sham stimulation will be trained on the correct locations for each TEA device and will receive an additional 4 weeks of treatment with the device. Note: The gastric emptying breathalyzer test (GEBT) was removed, and the two-day visits were shortened to one-day to improve patient recruitment and retention.
Interventions
DEVICEtranscutaneous electrical accustimulation at treatment point.
The transcutaneous electrical accustimulator (TEA) device administers a mild electrical shock through the skin, similar to acupuncture at a location previously seen to provide benefit. The precise distinction between sham and experimental accustimulation is not described upon registration to reduce unblinding risk, to maintain scientific integrity.
DEVICEtranscutaneous electrical accustimulation at sham point.
The transcutaneous electrical accustimulator (TEA) device administers a mild electrical shock through the skin, similar to acupuncture at a location which has not been shown to provide benefit. The precise distinction between sham and experimental accustimulation is not described upon registration to reduce unblinding risk, to maintain scientific integrity.
Sponsors
University of Michigan
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Half of subjects will be randomized to the sham arm, and half will be randomized to the treatment arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* At least a 3-month history of diabetic gastroparesis symptoms on an on-going basis; at least one severe gastroparetic symptom or two moderate gastroparetic symptoms (e.g. vomiting, nausea, early satiety, bloating, or epigastric or abdominal pain) during the screening. * Documented delayed gastric emptying within past 3 years * Stable concomitant medications, defined as no changes in regimen for at least 2 weeks prior to the experiment (daily adjustments of insulin doses are permitted if patient has diabetes)
Exclusion criteria
* Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube * History of gastric surgery such as fundoplication, gastrectomy, or vagotomy * Symptoms suggestive of gastroparesis with no diagnosis of diabetes * Pregnancy or expect to conceive during the course of the study * Uncontrolled diabetes mellitus (HbA1c \> 11%). * Having any implanted medical device, such as cardiac pacemaker or Entera device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD) | Up to 84 days | The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD) symptom daily score was generated by summing the scores on each of five symptom items (nausea, early satiety, postprandial fullness, upper abdominal pain, and number of vomiting episodes), each ranging from 0 (none) to 4 (very severe) and then dividing by 5, that is the number of items within the gastroparesis related symptom score. The minimum score was 0 and the maximum score was 4. Higher numbers indicated greater symptom impact. Scores will be compared from day 0 to day 84. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 36-Item Short Form Survey Instrument (SF-36) to Measure Quality of Life (QOL) | 8 weeks | A 36-question assessment to score overall quality of life. The SF-36 consisted of eight health domains with questions, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0-100 scale on the assumption that each question carried equal weight. The scores from those domains were then averaged together for a final score within a full range of 0-100, with higher values indicating greater function and 100 representing the highest level of functioning possible. |
| Gastric Accommodation | 8 weeks | A water-satiety drink test was performed during which the participant was asked to drink at a speed of 60ml/min until reaching the maximum tolerable volume (MTV). Results reflect the maximum tolerable volume of the water-satiety drinking test. |
| Electrogastrogram (EGG) | Visit 1 and visit 2 at 8 weeks | EGG was performed twice at both the baseline and at the 8-week visit. One 30-minute EGG was performed prior to the gastric accommodation test, and one 30-minute EGG was performed after the nutrient drink test. The goal was to measure gastric slow waves, which act as an indirect measure of gastric transit time. The difference in slow waves was compared pre- and post- gastric accommodation. Slow waves were also compared between visit 1 and visit 2. The percentage of normal gastric slow waves was previously used to predict delayed gastric emptying in participants with gastroparesis. Higher percentage of normal slow waves suggests an improvement in gastric emptying. |
| Electrocardiogram (ECG) - High-frequency Power (HFn) | 8 weeks | ECG recorded while sitting 30 minutes b/f drinking (fasting) and 30 minutes after drinking water. Same procedure used at first visit (pretreatment) and second visit (post-treatment week 8). Goal was to measure autonomic function by calculating heart rate variability (HRV). Artifacts from recoded ECG signal were removed and R-peaks were detected. Time interval b/w successive R-peaks (RR interval) was calculated to generate HRV signal, which was used to calculate HRV parameters. Power w/i 0.15-0.40 Hz frequency band was defined as high-frequency (HF) power, while power w/i 0.04-0.15 Hz band was defined as low-frequency (LF) power. Normalized high-frequency power (HFn) was calculated as HFn = HF/HF+LF. HFn showed vagal/parasympathetic activity, with higher values indicating more active parasympathetic response and more responsive autonomic system. Pre-drinking (fasting) value of each HRV parameter at baseline (week 0) was compared to week 8 (after treatment) for both TEA and Sham groups. |
| Electrocardiogram (ECG) - Sympathetic Index (SI) | 8 weeks | The ECG was recorded in sitting position for 30 minutes before drinking (under fasting state) and 30 minutes after drinking water in sitting position. The same procedure was followed during first visit (pretreatment) and during the second visit (post-treatment week 8). The goal is to measure autonomic function via calculating the heart rate variability (HRV). The artifacts from the recoded ECG signal were removed and R-peaks were detected. The time interval between successive R peaks (the RR interval) was calculated to generate the HRV signal, which was used to calculate the HRV parameters. Sympathetic Index (SI) is HRV marker of Sympathetic Nervous system activity, with lower number meaning lower sympathetic activity and high numbers indicating greater sympathetic activity. The pre-drinking (fasting) value of each HRV parameter at baseline (week 0) was compared to that at week 8 (after treatment) for both TEA and Sham groups. |
| Electrocardiogram (ECG) - LFn/HFn Ratio | 8 weeks | The ECG was recorded in sitting position for 30 minutes before drinking (under fasting state) and 30 minutes after drinking water in sitting position. The same procedure was followed during first visit (pretreatment) and during the second visit (post-treatment week 8). The goal was to measure autonomic function via calculating the heart rate variability (HRV). The artifacts from the recoded ECG signal were removed and R-peaks were detected. The time interval between successive R peaks (the RR interval) was calculated to generate the HRV signal, which was used to calculate the HRV parameters. The LFn/HFn ratio reflects autonomic balance, with higher value indicating the autonomic balance shifts towards the sympathetic, which a lower value indicates that the autonomic balance shifts towards the parasympathetic. The pre-drinking (fasting) value of each HRV parameter at baseline (week 0) was compared to that at week 8 (after treatment) for both TEA and Sham groups. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBorko Nojkov, MD
University of Michigan
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 51.45 years STANDARD_DEVIATION 12.7382 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Region of Enrollment United States | 41 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 20 | 0 / 13 |
| other Total, other adverse events | 3 / 21 | 1 / 20 | 0 / 13 |
| serious Total, serious adverse events | 1 / 21 | 3 / 20 | 0 / 13 |
Outcome results
None listed