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

October 21, 2019 updated by: Adrian Vella, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline
a saline infusion will be started and maintained till the end of the study at 1300 (300 minutes).
Other: Saline
Active Comparator: Exendin-9,39 @ 300
Exendin-9,39 @ 300pmol/kg/min
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
Active Comparator: Exendin-9,39 @ 750
Exendin-9,39 @ 750pmol/kg/min
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calories consumed during buffet meal test
Time Frame: 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.
approximately 300 minutes after initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

April 18, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Actual)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 21, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 14-002150
  • UL1RR024150 (U.S. NIH Grant/Contract)
  • R01DK082396 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Saline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe