Gastric Electrical Stimulator Off: See How It Changes Insulin and Glucose
Official title: Defining the Effect of Gastric Electrical Stimulation on Serum Insulin Levels in Human Subjects
Run by Indiana University · NCT07635576 · Data updated 2026-11-12
This study tests whether temporarily turning off a gastric electrical stimulator in adults with gastroparesis changes insulin, C-peptide, GLP-1, and glucose levels.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Status | Recruiting |
| Started | July 23, 2026 |
| Main results expected | July 31, 2028 |
| Study ends | July 31, 2028 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT07635576 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18+ with gastroparesis who have had a GES implanted for at least 3 months and are willing to undergo up to eight blood draws over about 5.5 hours.
✕Probably not a fit
Participants who do not experience metabolic changes from GES deactivation or who do not have the required implanted device may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-visit trial enrolls up to 32 adults with gastroparesis who already have a gastric stimulation device. Participants are randomized to either continue GES as usual or turn it off for four hours while blood samples and monitoring are collected. After an overnight fast, subjects are assessed with IV access, ECG leads, and periods of baseline, off-stimulation, and recovery, with multiple blood draws to measure metabolic hormones and glucose. Aims are to characterize metabolic changes when GES is temporarily deactivated.
Why it matters
Potential benefit: If successful, the study could clarify whether GES modulation affects metabolic signals related to glucose control in gastroparesis patients.
How similar studies have gone: Prior work has explored gastric stimulation effects on autonomic and metabolic parameters, but this particular off-on design with insulin/glucose endpoints is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years of age. * Documented diagnosis of gastroparesis * Not taking diabetic prescribed exogenous insulin. * Patient has a GES device that has been implanted for at least 3 months. * Willing to give up to 8 blood samples. * Willing to lie in a bed for up to 5.5 hours. Exclusion Criteria: * Pregnancy * History of allergic reaction to EKG lead placement adhesives. * Unable to give informed consent. * Unwilling to give up to 8 5 ml blood samples. * Unwilling to lie in a bed for up to 5.5 hours.
Where it's running
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Indiana University Hospital
Indianapolis, Indiana, United States Recruiting
Study contacts
- Principal investigator: Thomas V Nowak, MD — IU School of Medicine/IU Health
- Study coordinator: Maureen V Schilling, BS
- Email: maschi@iu.edu
- Phone: 3172782064
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.