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ID07635576

Evaluating the Impact of Turning Off Gastric Electrical Stimulation on Hormone and Insulin Levels in Adults with Gastroparesis Using a Gastric Electrical Stimulator

Led by Indiana University · Updated on 2026-06-09

32

Participants Needed

2

Research Sites

113 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to understand how turning off a Gastric Electrical Stimulator GES affects insulin, C-peptide, GLP-1, and glucose levels in adults with gastroparesis who have had the device implanted for at least three months and are not using prescribed insulin. The study also analyzes heart rate variability through EKG recordings to assess autonomic nervous system activity during device on and off periods. Participants are divided into two groups one with the GES turned off for up to four hours, and a control group where the device remains on. The study involves three consecutive periods a 20-minute baseline with the device on, a four-hour experimental period with the device off or left on for controls, and a 20-minute recovery with the device turned back on. Blood samples are collected multiple times during these periods to measure hormone and glucose levels. During the study, participants lie in bed while EKG electrodes monitor heart function. Researchers analyze blood samples and heart rate data to evaluate changes caused by turning off the stimulator. The study measures effects over up to four hours per participant, with multiple blood draws and continuous heart monitoring to assess hormonal and autonomic changes.

CONDITIONS

Brief Title

Effect of Gastric Electrical Stimulation on Serum Insulin Levels

Research Team

M

Maureen V Schilling, BA

T

Thomas V Nowak, MD

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