Effect of Gastric Electrical Stimulation on Serum Insulin Levels

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.

Detailed Description

Up to thirty-two adult patients with gastroparesis who have undergone implantation of a gastric stimulation device at least three months prior may participate in this study, which will be completed at a single study visit. 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. After an overnight fast, consented and eligible patients are placed in the supine position on a hospital bed, and an intravenous line is inserted and capped. EKG electrodes will be placed on the chest, arms/legs, behind each ear and just under the jaw on each side to record cardiac and vagal nerve activity. The study consists of three separate and consecutive periods: 1. Baseline, a 20-minute period during which GES is left ON at each patient's pre-study settings; 2. Experimental, a 4-hour period during which the GES device is turned OFF for participants in the experimental group; 3. Recovery, a 20-minute period during which GES is turned back ON to the patient's pre-study settings for participants in the experimental group. A 5-ml sample of blood will be collected from each patient after placement of the flexible IV catheter secured with tape, and after the Baseline, and Recovery study periods. During the Experimental period a blood sample is withdrawn after 30 minutes and then again at the 1-hour, 2-hour, 3-hour and 4-hour intervals through a flexible IV catheter secured with tape, with the possibility of up to 8 blood draws over the duration of the study. EKG and vagal nerve activity will be recorded continuously through the 3 study periods.

Eligibility Criteria

Interventions