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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128581
• Other study ID #: 14-002150
• Secondary ID: R01DK082396UL1RR
• Status: Completed
• Phase: Phase 1
• Start date: May 2014
• Est. completion date: July 2019

Study information

• Verified date: October 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: July 2019
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Obesity
• Roux-en-Y Gastric Bypass

Intervention

Drug:
• 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

Other:
• Saline

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	National Center for Research Resources (NCRR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calories consumed during buffet meal test	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.	approximately 300 minutes after initiation

External Links

•   Mayo Clinic Clinical Trials