Effect of Gastric Electrical Stimulation on Serum Insulin Levels
ConditionGastroparesis Nondiabetic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIndiana University
About this trial
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
This trial does not accept healthy volunteersQualifiers
• 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.
Disqualifiers
• 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.
Trial design
Design model
Single group
Treatments tested in this trial
Gastric Electrical Stimulator
DeviceDevice will either be turned off for the duration of the experiment, or the device will be left on for the duration of the experiment
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: The OFF GroupExperimental treatment 1 intervention
Group B: SHAM GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Definition of Effect
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.
Time frame
Up to four hours depending on the subject's preference/tolerability.Secondary outcomes
1
Comparing Hormone Levels
To compare the changes in serum insulin and C-peptide levels after 4-hour withdrawal of gastric electrical stimulation to a control group that does not undergo withdrawal of gastric electrical stimulation.
Time frame
Up to four hours depending on the subject's preference/tolerability.2
Definition of 4-Hour Withdrawl of GES Device
To define the effect of prolonged four-hour withdrawal of gastric electrical stimulation on serum GLP-1 and glucose levels in human subjects. GLP-1 and glucose are co-secondary end points.
Time frame
Up to four hours depending on the subject's preference/tolerability.3
Changes in Glucose and GLP-1 Levels
To compare the changes in serum GLP-1 and glucose levels after 4-hour withdrawal of gastric electrical stimulation to a control group that does not undergo withdrawal of gastric electrical stimulation.
Time frame
Up to four hours depending on the subject's preference/tolerability.Other outcomes
1
Tertiary Objective
To determine whether changes noted in serum levels of insulin, C-peptide, GLP-1 and glucose are associated with alterations in heart rate variability and sympathetic and parasympathetic autonomic activation.
Time frame
Up to four hours depending on the subject's preference/tolerability.Sponsors and contacts
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Source ClinicalTrials.gov