Incretin Hormone Antagonism After Bariatric Surgery

Bariatric Surgery Clinical Trial

— INCA-BAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03950245
• Other study ID #: MH-INKA-BAR-19
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: April 16, 2021

Study information

• Verified date: January 2022
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 16, 2021
• Est. primary completion date: April 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

Other:
• Placebo
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during saline infusion.
• GLP-1 antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin 9-39 and saline infusion.
• GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during GIP(3-30) and saline infusion.
• GLP-1 and GIP antagonism
Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin and GIP(3-30) infusion.

Locations

Country	Name	City	State
Denmark	Department of Endocrinology	Hvidovre
Denmark	Hvidovre Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iAUC glucose	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	Beta-cell glucose sensitivity (ß-GS)	Main comparison between groups: delta ß-GS (ß-GS exendin(9-39) test day - ß-GS GIP(3-30) test day) in the RYGB group compared to the SG group	240 minutes