Incretin Hormone Antagonism After Bariatric Surgery (INCA-BAR)

Hvidovre University Hospital

Status: Completed

Conditions: Bariatric Surgery

Treatments: Other: GLP-1 antagonism; Other: Placebo; Other: GIP antagonism; Other: GLP-1 and GIP antagonism

Study type: Interventional

Funder types: Other

Identifiers

NCT03950245

MH-INKA-BAR-19

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 3 patient groups

Gastric bypass operated patients

Other group

Description:

Four test days in a randomized, patient-blinded, cross-over design

Treatment:

Other: GLP-1 antagonism

Other: GIP antagonism

Other: Placebo

Other: GLP-1 and GIP antagonism

Sleeve gastrectomy operated patients

Other group

Description:

Four test days in a randomized, patient-blinded cross-over, design

Treatment:

Other: GLP-1 antagonism

Other: GIP antagonism

Other: Placebo

Other: GLP-1 and GIP antagonism

Un-operated controls

Other group

Description:

Four test days in a randomized, patient-blinded cross-over, design

Treatment:

Other: GLP-1 antagonism

Other: GIP antagonism

Other: Placebo

Other: GLP-1 and GIP antagonism