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Incretin Hormone Antagonism After Bariatric Surgery (INCA-BAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03950245
Recruitment Status : Completed
First Posted : May 15, 2019
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
Morten Gadegaard Hindsø, MD, Hvidovre University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Other: Placebo Other: GLP-1 antagonism Other: GIP antagonism Other: GLP-1 and GIP antagonism Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : April 16, 2021
Actual Study Completion Date : April 16, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950245


Locations
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Denmark
Department of Endocrinology
Hvidovre, Denmark, 2650
Hvidovre Hospital
Hvidovre, Denmark
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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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
More Information
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Responsible Party: Morten Gadegaard Hindsø, MD, Principal Investigator, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03950245    
Other Study ID Numbers: MH-INKA-BAR-19
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Morten Gadegaard Hindsø, MD, Hvidovre University Hospital:
glucagon-like peptide-1
glucose-dependent insulinotropic polypeptide
Roux-en-Y gastric bypass
sleeve gastrectomy
gastric bypass
 bariatric surgery
glucose
diabetes
exendin(9-39)
GIP(3-30)
Additional relevant MeSH terms:
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Glucagon
Glucagon-Like Peptide 1
Incretins
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents