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Completed

NCT Number: NCT03950245

Incretin Hormone Antagonism After Bariatric 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.

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Key information

Conditions

Bariatric Surgery Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology, Hvidovre, Denmark

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Other

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during saline infusion.

GLP-1 antagonism

Other

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin 9-39 and saline infusion.

GIP antagonism

Other

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during GIP(3-30) and saline infusion.

GLP-1 and GIP antagonism

Other

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin and GIP(3-30) infusion.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study 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

Acronym: INCA-BAR

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 15, 2019
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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