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
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
Treatments tested in this trial
- Gastric Electrical Stimulator
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov