Incretin Hormone Antagonism After Bariatric Surgery

Not Applicable

Completed

• Conditions: Bariatric Surgery
• Interventions: Other: Placebo; Other: GLP-1 antagonism; Other: GIP antagonism; Other: GLP-1 and GIP antagonism

• Registration Number: NCT03950245
• Lead Sponsor: Hvidovre University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-15
• Study Start: 2019-07-01
• Primary Completion: 2021-04-16
• Study Completion: 2021-04-16
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Gastric bypass operated patients	GIP antagonism	Four test days in a randomized, patient-blinded, cross-over design
Un-operated controls	GLP-1 antagonism	Four test days in a randomized, patient-blinded cross-over, design
Gastric bypass operated patients	GLP-1 antagonism	Four test days in a randomized, patient-blinded, cross-over design
Gastric bypass operated patients	Placebo	Four test days in a randomized, patient-blinded, cross-over design
Un-operated controls	Placebo	Four test days in a randomized, patient-blinded cross-over, design
Un-operated controls	GLP-1 and GIP antagonism	Four test days in a randomized, patient-blinded cross-over, design
Gastric bypass operated patients	GLP-1 and GIP antagonism	Four test days in a randomized, patient-blinded, cross-over design
Sleeve gastrectomy operated patients	Placebo	Four test days in a randomized, patient-blinded cross-over, design
Sleeve gastrectomy operated patients	GIP antagonism	Four test days in a randomized, patient-blinded cross-over, design
Un-operated controls	GIP antagonism	Four test days in a randomized, patient-blinded cross-over, design
Sleeve gastrectomy operated patients	GLP-1 antagonism	Four test days in a randomized, patient-blinded cross-over, design
Sleeve gastrectomy operated patients	GLP-1 and GIP antagonism	Four test days in a randomized, patient-blinded cross-over, design

Primary Outcome Measures

Name	Time	Method
iAUC glucose	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

Name	Time	Method
Beta-cell glucose sensitivity (β-GS)	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

Trial Locations

Locations (2)

Department of Endocrinology; 🇩🇰 Hvidovre, Denmark

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark