Effect of Gastric Electrical Stimulation on Serum Insulin Levels

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07635576
Status
Recruiting
Apply to this trial

Conditions

  • Gastroparesis Nondiabetic

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Gastric Electrical Stimulator — DEVICE
    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

Study Details

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.

Key Dates

Start date
Jun 8, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2028
Completion
Sep 30, 2030

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: The OFF Group
    This group of subjects will have their GES interrogated and observed as well as having the device turned off for the duration of the experiment. The device will then be re-interrogated and turned back on at the end of the experiment.
  • Sham Comparator: SHAM Group
    This group of subjects will have their GES interrogated and observed yet will not have the device turned off for the duration of the experiment. The device will then be re-interrogated at the end of the experiment. This is to retain the illusion of the device being turned back on.

Primary Outcome Measure

Definition of Effect [ Time Frame: Up to four hours depending on the subject's preference/tolerability. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Indiana University HospitalIndianapolisIndiana46202
Maureen V Schilling, BS
[email protected]
317-278-2064
Thomas V Nowak, MD
[email protected]
3179484272
Thomas V Nowak, MD (PRINCIPAL_INVESTIGATOR)
Indiana University HospitalIndianapolisIndiana46202
Maureen Schilling, BA
[email protected]
317-278-2064
Thomas V Nowak, MD
[email protected]
3179484272

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By research site
Indiana University Hospital· Indianapolis, IN

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