RecruitingNot ApplicableNCT07635576

Effect of Gastric Electrical Stimulation on Serum Insulin Levels

Defining the Effect of Gastric Electrical Stimulation on Serum Insulin Levels in Human Subjects


Sponsor

Indiana University

Enrollment

32 participants

Start Date

Jun 8, 2026

Study Type

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

Min Age: 18 YearsMax Age: 70 Years

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

DEVICEGastric Electrical Stimulator

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)

Indiana University Hospital

Indianapolis, Indiana, United States

Indiana University Hospital

Indianapolis, Indiana, United States

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NCT07635576


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