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NCT02952963 Clinical Trial

Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass

Severe Obesity Clinical Trial

Official title:
Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02952963
Other study ID # IJ-GALDE3-16
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 2016
Est. completion date November 2020

Study information
Verified date November 2020
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the efffects of bile acid and bile acids sequestrants on GLP-1 secretion, in patients after Roux-en-Y gastric bypass.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date November 2020
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Uncomplicated RYGB performed minimum 3 months prior to the study. - Fasting glucose < 7,0 mM, HbA1c < 48 mmol/mol 3 months after RYGB Exclusion Criteria: - Fasting plasma glucose > 7,0 mM, HbA1c > 48 mmol/mol 3 months after RYGB - Dysregulated thyroid diseases, use of antithyroid treatment. - Late diabetic complications as retinopathy, renal insufficiency, neuropathy or previous pancreatitis. - Complications to RYGB. Documented reactive hypoglycaemia, severe dumping (vomiting, diarrhea, severe abdominal pain after food intake) - Cholecystectomy.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Chenodeoxycholic Acid

• Colesevelam

Locations
Country Name City State
Denmark Hvidovre University Hospital Hvidovre DK

Sponsors (2)
Lead Sponsor Collaborator
Hvidovre University Hospital University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary GLP-1 secretion (evaluated by iAUC) -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes after medicin intake.
Secondary Glucose levels -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Secondary PYY secretion -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Secondary Glucagon secretion -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Secondary GIP secretion -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Secondary Insulin secretion -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Secondary C-peptide secretion -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Secondary CCK secretion -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Secondary Total ghrelin -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Secondary Total bile acid secretion -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Secondary Bile acids fractions / FGF-19 concentrations -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Secondary Appetite measurements (VAS-score) -10, 30, 60, 120, 180 and 240 minutes
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