Exendin-9,39 and Satiety After Bariatric Surgery

April 22, 2020 updated by: Adrian Vella, Mayo Clinic
The overall aim of the application is to determine the contribution of the elevated incretin hormone concentrations seen after certain types of bariatric surgery to the regulation of food intake and satiety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Both Sleeve Gastrectomy (SG) and Roux-en-Y Gastric Bypass (RYGB) increase GLP-1 concentrations, although this is of lesser magnitude in SG compared to RYGB. Data suggests that endogenous GLP-1 is at least partially responsible for reducing free-choice caloric intake after RYGB, providing a mechanism underlying differences between procedures. Inhibition of GLP-1 action with Exendin-9,39 after RYGB accelerates gastric emptying. These observations suggest that factors other than anatomy regulate the upper gastrointestinal response to food ingestion. It is therefore reasonable to consider that the postprandial rise in GLP-1 might affect feeding behavior after RYGB, and to a lesser extent SG, where the increase in GLP-1 is less marked.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergone either sleeve gastrectomy or Roux-en-Y Gastric Bypass surgery within prior 2 years
  • Healthy, with no active systemic illness

Exclusion Criteria:

  • Pregnancy
  • Functional or organic bowel symptoms
  • Systemic illness
  • Diabetes
  • Bariatric surgery > 2 years

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline
0.9% NaCL (saline) intravenously for 6 hours.
Drug: Saline
Subjects will be studied on 2 occasions, in random order. During the saline study they will be infused with saline.
Active Comparator: Exendin-9,39
Exendin-9,39 intravenously for 6 hours.
Drug: Exendin-9,39
Subjects will be studied on 2 occasions, in random order. During the Exendin-9,39 study day they will be infused with Exendin-9,39. Exendin-9,39 blocks the actions of specific hormones called incretins, that are produced in the gut in health and in larger quantities after gastric bypass surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caloric Intake
Time Frame: 5 hours
caloric intake from a free choice buffet within 5 hours after ingestion of a standard meal
5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal Transit Measured Using Scintigraphy
Time Frame: 4 hours
Time taken to empty 50% of stomach contents (GE50) measured using scintigraphy over the 4 hours after ingestion of a labeled meal
4 hours

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Collaborators

The Obesity Society

Investigators

  • Principal Investigator: Adrian Vella, Mayo Clinic

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.

General Publications

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

June 1, 2016

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

May 16, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (Estimate)

May 20, 2016

Study Record Updates

Last Update Posted (Actual)

May 1, 2020

Last Update Submitted That Met QC Criteria

April 22, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-001973

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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