Recruiting

Observational Study

Sponsor:

Indiana University

Code:

NCT07635576

Conditions

Gastroparesis Nondiabetic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gastric Electrical Stimulator

Study Details

Brief summary:

The goal of this study is to determine how much effect turning off an individual's Gastric Electrical Stimulator (GES) for up to four hours will have on levels of insulin, C-peptide, GLP-1 and glucose levels.

Conditions

Gastroparesis Nondiabetic

Study ID

NCT07635576

Start date

Jul 23, 2026

Status verified date

Sep, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

no intervention: Control Group

This group of subjects will undergo the same procedures as the experimental group, except that their GES will not be turned off during the experimental period.

Interventions

Gastric Electrical Stimulator

Device will either be turned off for the duration of the experimental period.

Primary outcome measure

  • Change in serum insulin [ Time Frame: Day 1 ]
  • Change in serum C-peptide [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Maureen V Schilling, BS

3172782064maschi@iu.edu

Thomas V Nowak, MD

3179484272tvnowak@iu.edu

Locations

Indiana University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Maureen V Schilling, BS

3172782064maschi@iu.edu

Thomas V Nowak, MD

317-948-4272tvnowak@iu.edu

Principal Investigator:

Thomas V Nowak, MD

More Information

Sponsor

Indiana University

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Indiana University on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.