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

Phase 4

Completed

• Conditions: Severe Obesity
• Interventions: Drug: Chenodeoxycholic Acid; Drug: Colesevelam

• Registration Number: NCT02952963
• Lead Sponsor: Hvidovre University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-02
• Primary Completion: 2017-12
• Status Verified: 2020-11
• Study Completion: 2020-11
• Last Update Submitted: 2020-11-25
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Chenodeoxycholic Acid and Colesevelam	Colesevelam	Chenodeoxycholic Acid (1250 mg) and Colesevelam (3,75 g) dissolved in 200 ml water. Here after 50 ml clean water.
Chenodeoxycholic Acid and Colesevelam	Chenodeoxycholic Acid	Chenodeoxycholic Acid (1250 mg) and Colesevelam (3,75 g) dissolved in 200 ml water. Here after 50 ml clean water.
Chenodeoxycholic Acid	Chenodeoxycholic Acid	Chenodeoxycholic Acid (1250 mg) dissolved in 200 ml water. Here after 50 ml clean water.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
C-peptide secretion	-10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
CCK secretion	-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Glucose levels	-10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Total ghrelin	-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Total bile acid secretion	-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Bile acids fractions / FGF-19 concentrations	-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Appetite measurements (VAS-score)	-10, 30, 60, 120, 180 and 240 minutes
PYY secretion	-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Glucagon secretion	-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
GIP secretion	-10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
Insulin secretion	-10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, DK, Denmark