Overview

This trial is active, not recruiting.

Conditions obesity, diabetes, roux-en-y gastric bypass
Treatments exendin-9,39, saline
Phase phase 1
Sponsor Mayo Clinic
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Placebo Comparator)
a saline infusion will be started and maintained till the end of the study at 1300 (300 minutes).
saline
(Active Comparator)
Exendin-9,39 @ 300pmol/kg/min
exendin-9,39
use Exendin-9,39 @ 750pmol/kg/min and Exendin-9,39 @ 300pmol/kg/min to block endogenous GLP-1 in humans after gastric bypass and determine contribution of GLP to satiety after meal ingestion
(Active Comparator)
Exendin-9,39 @ 750pmol/kg/min
exendin-9,39
use Exendin-9,39 @ 750pmol/kg/min and Exendin-9,39 @ 300pmol/kg/min to block endogenous GLP-1 in humans after gastric bypass and determine contribution of GLP to satiety after meal ingestion

Primary Outcomes

Measure
Calories consumed during buffet meal test
time frame: approximately 300 minutes after initiation

Eligibility Criteria

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.

Additional Information

Official title A Dose-response Study of the Effects of Exendin-9,39 on Gastrointestinal Symptoms and Food Intake.
Principal investigator Adrian Vella, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.