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

Phase 4

Completed

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

• Registration Number: NCT02876484
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-07-01
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-23
• Primary Completion: 2017-06
• 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: 12

Inclusion Criteria

• Uncomplicated RYGB performed minimum 3 months prior to the study.
• Fasting plasma 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
Placebo	Water	Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. 25 ml water
Chenodeoxycholic Acid	Chenodeoxycholic Acid	Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Chenodeoxycholic acid (1250 mg) mixed in 25 ml yoghurt
Colesevelam	Colesevelam	Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Colesevelam (3,75 g) dissolved in 25 ml water and mixed in 25 ml yoghurt.
Colesevelam x 2	Colesevelam	plus (on another study day) 3,75 g colesevelam administered the evening before the experiment. Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Colesevelam (3,75 g) dissolved in 25 ml water and mixed in 25 ml yoghurt.

Primary Outcome Measures

Name	Time	Method
GLP-1 secretion (evaluated by iAUC)	-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes after mixed meal

Secondary Outcome Measures

Name	Time	Method
Insulin secretion	-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
PYY secretion	-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Bile acids/FGF19 concentrations	-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Glucose levels	-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
PCM levels	Baseline, 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 minutes
CCK secretion	0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Total bile acid secretion	0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Appetite measurements (VAS-score)	0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
C-peptide secretion	Baseline, 0, 5, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes
Glucagon secretion	Baseline, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes
GIP secretion	0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Ghrelin	0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark