Incretin Hormone Antagonism After Bariatric Surgery (INCA-BAR)

January 31, 2022 updated by: Morten Gadegaard Hindsø, MD, Hvidovre University Hospital

Importance of Endogenous Glucagon-like Peptide-1 and Glucose-dependent Insulinotropic Polypeptide for Postprandial Glucose Metabolism After Roux-en-Y Gastric Bypass and Sleeve Gastrectomy Surgery

Using the glucagon-like peptide-1 (GLP-1) antagonist exendin(9-39) and the glucose-dependent insulinotropic peptide (GIP) antagonist GIP(3-30), the purpose of this study is to clarify the importance of endogenous GLP-1 and GIP for postprandial glucose metabolism after RYGB and SG in subjects with normal glucose tolerance. We hypothesize that GLP-1 is more important after RYGB, and GIP is more important after SG, for postprandial glucose tolerance and beta-cell function. A group of un-operated subjects with normal glucose tolerance will serve as controls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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

  • Denmark
      • Hvidovre, Denmark
        • Hvidovre Hospital
      • Hvidovre, Denmark, 2650
        • Department of Endocrinology

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria, surgery groups:

  • Age > 18 years
  • RYGB or SG operation > 12 months prior to inclusion
  • Weight stable (± 3 kg during the last month)
  • HbA1c < 48 mmol/mol before surgery, and no history of diabetes
  • HbA1c < 48 mmol/mol and fasting plasma glucose < 6.1 mmol/l at inclusion

Inclusion Criteria, control group:

  • Age > 18 years
  • no former RYGB- or SG operation
  • Weight stable (± 3 kg during the last month)
  • HbA1c < 48 mmol/mol, fasting plasma glucose < 6.1 mmol/l and no history of diabetes

Exclusion Criteria:

  • Thyrotoxicosis or inadequately treated hypothyreosis
  • Hemoglobin < 6.5 mmol/l at inclusion
  • Pregnancy or breast feeding
  • Medication affecting the planned examinations

Matching between groups

  • Age
  • Sex
  • BMI at inclusion and for surgery groups also pre-surgery BMI

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Gastric bypass operated patients
Four test days in a randomized, patient-blinded, cross-over design
Other: Placebo
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during saline infusion.
Other: GLP-1 antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin 9-39 and saline infusion.
Other: GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during GIP(3-30) and saline infusion.
Other: GLP-1 and GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin and GIP(3-30) infusion.
Other: Sleeve gastrectomy operated patients
Four test days in a randomized, patient-blinded cross-over, design
Other: Placebo
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during saline infusion.
Other: GLP-1 antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin 9-39 and saline infusion.
Other: GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during GIP(3-30) and saline infusion.
Other: GLP-1 and GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin and GIP(3-30) infusion.
Other: Un-operated controls
Four test days in a randomized, patient-blinded cross-over, design
Other: Placebo
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during saline infusion.
Other: GLP-1 antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin 9-39 and saline infusion.
Other: GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during GIP(3-30) and saline infusion.
Other: GLP-1 and GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin and GIP(3-30) infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iAUC glucose
Time Frame: 240 minutes
Main comparison between groups: delta iAUC glucose (iAUC exendin(9-39) test day - iAUC GIP(3-30) test day) in the RYGB group compared to the SG group
240 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beta-cell glucose sensitivity (β-GS)
Time Frame: 240 minutes
Main comparison between groups: delta β-GS (β-GS exendin(9-39) test day - β-GS GIP(3-30) test day) in the RYGB group compared to the SG group
240 minutes

Collaborators and Investigators

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

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Kirstine N Bojsen-Møller, MD, PHD, Dept. of Endocrinology, Hvidovre Hospital, Denmark
  • Principal Investigator: Morten G Hindsø, MD, Dept. of Endocrinology, Hvidovre Hospital, Denmark

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 (Actual)

July 1, 2019

Primary Completion (Actual)

April 16, 2021

Study Completion (Actual)

April 16, 2021

Study Registration Dates

First Submitted

May 13, 2019

First Submitted That Met QC Criteria

May 13, 2019

First Posted (Actual)

May 15, 2019

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH-INKA-BAR-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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