Defining the Effect of Gastric Electrical Stimulation on Serum Insulin Levels in Human Subjects
Indiana University
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.
Description
Up to thirty-two adult patients with gastroparesis who have undergone implantation of a gastric stimulation device at least three months prior are candidates for study. Diabetic patients who are taking exogenous insulin are excluded from study The study consists of two groups, an EXPERIMENTAL group that undergoes turning off the GES and a CONTROL group that does not undergo the turning off of the GES. The subjects are randomized to either the control or experimental group. The study Coordinator will create a block randomization schedule in Excel (Block Randomization in Clinical Trials: Video T…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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.
Interventions
- DeviceGastric 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
Locations (2)
- Indiana University HospitalIndianapolis, Indiana
- Indiana University HospitalIndianapolis, Indiana