A Dose-response of the Effects of Exendin-9,39 on GI Symptoms and Food Intake
This trial is active, not recruiting.
|Conditions||obesity, diabetes, roux-en-y gastric bypass|
|Collaborator||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Start date||May 2014|
|End date||March 2015|
|Trial size||3 participants|
|Trial identifier||NCT02128581, 14-002150, R01DK082396, UL1RR024150|
Exendin-(9,39) has been shown to have effects on beta-cell function, and after gastric bypass, to accelerate gastrointestinal transit. - infused at rates of 300pmol/kg/min. Given that gastrointestinal transit is typically delayed by Glucagon-Like Peptide-1 (GLP-1) and also that this hormone causes decreased food intake through increased satiation, it is reasonable to expect an effect of Exendin-9,39 on appetite. This may help explain the effects of gastric bypass on food intake. To examine the effect of Exendin on food intake we propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion. We will examine the presence of gastrointestinal symptoms as well as food intake in the immediate aftermath of a test meal and the subsequent hours.
|Endpoint classification||pharmacokinetics/dynamics study|
|Intervention model||crossover assignment|
|Primary purpose||basic science|
Calories consumed during buffet meal test
time frame: approximately 300 minutes after initiation
Male or female participants from 20 years up to 70 years old.
Inclusion Criteria: - Subjects who have undergone Roux en-Y Gastric Bypass at least 6 months prior to enrollment in the study. - Subjects without active systemic illness. Exclusion Criteria: - Subjects <20 years of age will not be studied to minimize the possibility of type 1 diabetes. - Subjects >70 years of age will not be studied to minimize the potential confounding effects of age on glucose tolerance.
|Official title||A Dose-response Study of the Effects of Exendin-9,39 on Gastrointestinal Symptoms and Food Intake.|
|Principal investigator||Adrian Vella, MD|
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