NCT07635576 · Indiana University
Effect of Gastric Electrical Stimulation on Serum Insulin Levels
What this study is about
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.
View original scientific description
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.
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
Primary outcome measures
Definition of Effect
Time frame: Up to four hours depending on the subject's preference/tolerability.
To define the effect of prolonged four-hour withdrawal of gastric electrical stimulation on serum insulin and C-peptide levels in human subjects. Insulin and C-peptide are co-primary end points.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Indianapolis, Indiana
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 9, 2026 · Source of record for eligibility and locations