A Dose-response of the Effects of Exendin-9,39 on GI Symptoms and Food Intake

Phase 1

Completed

• Conditions: Diabetes; Obesity; Roux-en-Y Gastric Bypass
• Interventions: Other: Saline; Drug: Exendin-9,39

• Registration Number: NCT02128581
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-18
• Study First Submitted QC: 2014-04-29
• Study Start: 2014-05
• Study First Posted: 2014-05-01
• Primary Completion: 2016-03
• Study Completion: 2019-07
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline	Saline	a saline infusion will be started and maintained till the end of the study at 1300 (300 minutes).
Exendin-9,39 @ 300	Exendin-9,39	Exendin-9,39 @ 300pmol/kg/min
Exendin-9,39 @ 750	Exendin-9,39	Exendin-9,39 @ 750pmol/kg/min

Primary Outcome Measures

Name	Time	Method
Calories consumed during buffet meal test	approximately 300 minutes after initiation	The calories consumed during buffet meal test at the end of each study test will help determine the effect of GLP-1 receptor blockade with Exendin-9,39 on food intake.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States