Defining the Effect of Gastric Electrical Stimulation on Serum Insulin Levels in Human Subjects
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• • 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.
Locations
United States
Indiana
Indiana University Hospital
RECRUITING
Indianapolis
Indiana University Hospital
RECRUITING
Indianapolis
Contact Information
Primary
Maureen V Schilling, BA
maschi@iu.edu
3172782064
Backup
Thomas V Nowak, MD
tvnowak@iu.edu
3179484272
Time Frame
Start Date: 2026-06-08
Estimated Completion Date: 2030-09-30
Participants
Target number of participants: 32
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Indiana University