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Effect of Gastric Electrical Stimulation on Serum Insulin Levels

NCT07635576 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-08-13

No results posted yet for this study

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.

Conditions

  • Gastroparesis Nondiabetic

Interventions

DEVICE

Gastric 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

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Thomas V Nowak, MD · IU School of Medicine/IU Health

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-23
Primary Completion
2028-07-31
Completion
2028-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07635576 on ClinicalTrials.gov