Effect of Gastric Electrical Stimulation on Serum Insulin Levels
Purpose
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.
Condition
- Gastroparesis Nondiabetic
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- 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.
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
- Masking Description
- One group will have their GES turned off for the duration of the experiment, and the second group will not have their GES turned off, but will not know of this as the device will be interrogated and observed in the same manner as the OFF group, except the device will not be turned off.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
More Details
- Status
- Recruiting
- Sponsor
- Indiana University
Detailed 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 Tutorial in Microsoft Excel)(10). The study Coordinator will use the Excel randomization schedule to assign the treatment and will administer the stimulus accordingly. No one will be blinded to any of the arms of the study. After an overnight fast, the patients are placed in the supine position on a hospital bed, and an intravenous line is inserted and capped. 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; 3. Recovery, a 20-minute period during which GES is turned back ON to the patient's pre-study settings. A 5-ml sample of blood will be removed from each patient after placement of the flexible IV catheter secured with tape, 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. Plasma samples are analyzed for glucose, C-peptide, GLP-1 and insulin levels. The analysis of variance is used to determine whether there is any significant effect of time on the resultant values. In a previous study we examined the variance of patient demographics (age, gender, and BMI). As patients with implanted electrical stimulators typically have different stimulator settings to control their symptoms, this arm of the study examines whether stimulation parameters such as pulse duration, amplitude or frequency have any effect on individual response to gastric electrical stimulation. A correlation coefficient analysis is used to determine if any variable shows a significant effect. During the study EKG electrodes are placed over the extremities and precordium and recordings continued during the respective Baseline, Experimental, and Recovery periods. EKG signals are digitized and downloaded to a computer for time domain power spectral analysis of heart rate variability using commercially available software. This analysis will determine the influence of sympathetic and parasympathetic mechanisms during the respective time periods.