Using electrical stimulation to treat gastroparesis in diabetic patients
Wearable Transcutaneous Electrical Acustimulation for Gastroparesis
This study is testing whether a special electrical device can help people with diabetes and gastroparesis feel better by improving their stomach function and reducing symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05362578 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Transcutaneous Electrical Accustimulator (TEA) device in alleviating gastrointestinal symptoms and improving gastric motility in patients with diabetic gastroparesis. Over a 12-week period, participants will undergo a non-invasive gastric functional test and be randomized into either a treatment group receiving actual stimulation or a sham group. Each participant will have two visits, with weekly follow-ups to monitor compliance and adverse events. After the initial 8 weeks, those in the sham group will receive the actual treatment for an additional 4 weeks.
Who should consider this trial
Good fit: Ideal candidates are individuals with a documented history of diabetic gastroparesis symptoms and delayed gastric emptying.
Not a fit: Patients who have undergone gastric surgery or have uncontrolled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from diabetic gastroparesis by alleviating their gastrointestinal symptoms.
How similar studies have performed: While the approach of using electrical stimulation for gastrointestinal issues is being explored, this specific application for diabetic gastroparesis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Borko Nojkov, MD — University of Michigan
- Study coordinator: Omar Daassa
- Email: odaassa@med.umich.edu
- Phone: 734-647-9994
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.