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NCT07635576
Effect of Gastric Electrical Stimulation on Serum Insulin Levels
Conditions: Gastroparesis Nondiabetic
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 32
Sponsor: Indiana University
Location: Indiana University Hospital Indianapolis Indiana
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07635576). StuddyBuddy aggregates publicly available trial information.
