Effect of Gastric Electrical Stimulation on Serum Insulin Levels
Defining the Effect of Gastric Electrical Stimulation on Serum Insulin Levels in Human Subjects
Indiana University
32 participants
Jun 8, 2026
INTERVENTIONAL
Conditions
Summary
The goal of this observational study is to determine how much effect turning the subject's Gastric Electrical Stimulator off for up to four hours will have on levels of insulin, C-peptide, GLP-1 and Glucose levels in patients with gastroparesis who have had a GES for at least three months, who are not taking diabetic prescribed exogenous insulin. EKG recordings will be made and analyzed for Heart Rate Variability and Power Spectral Analysis.
Eligibility
Inclusion Criteria6
- 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 Criteria5
- 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.
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Interventions
Device will either be turned off for the duration of the experiment, or the device will be left on for the duration of the experiment
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07635576