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Effect of Gastric Electrical Stimulation on Serum Insulin Levels

ConditionGastroparesis Nondiabetic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Parallel

Treatments tested in this trial

  • Gastric Electrical Stimulator

    Device

    Device will either be turned off for the duration of the experimental period.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: The OFF GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in serum insulin

To define the effect of prolonged four-hour withdrawal of gastric electrical stimulation on serum insulin.

Time frame
Day 1
2

Change in serum C-peptide

To define the effect of prolonged four-hour withdrawal of gastric in human subjects. Insulin and C-peptide are co-primary end points.

Time frame
Day 1

Secondary outcomes

1

Changes in serum glucose

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
Day 1
2

Changes in serum GLP-1

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
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Source ClinicalTrials.gov
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