Bariatric Surgery Clinical Trial
— INCA-BAROfficial 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
Verified date | January 2022 |
Source | Hvidovre University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Endocrinology | Hvidovre | |
Denmark | Hvidovre Hospital | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital |
Denmark,
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 |
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