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

Phase 4

Completed

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

• Registration Number: NCT02340247
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

The purpose of this study is to examine the effects of bile acids on GLP-1 secretion after Roux-en-Y gastric bypass.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-16
• Primary Completion: 2015-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-29
• Last Update Posted: 2016-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Uncomplicated RYGB performed minimum 3 months prior to the study.
• Fasting plasma glucose < 7.0mM, HbA1c < 48mmol/mol 3 months after RYGB.

Exclusion Criteria

• Fasting plasma glucose > 7.0mM, HbA1c > 48mmol/mol 3 months after RYGB.
• Dysregulated hypothyroidism, 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Water	150mL water
Ursodeoxycholic acid	Ursodeoxycholic Acid	Ursodeoxycholic acid (750mg) dissolved in 150mL water
Chenodeoxycholic acid	Chenodeoxycholic Acid	Chenodeoxycholic acid (1250mg) dissolved in 150mL water

Primary Outcome Measures

Name	Time	Method
GLP-1 secretion (evaluated by iAUC)	Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180

Secondary Outcome Measures

Name	Time	Method
PYY secretion (evaluated by iAUC)	Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Changes in bile acids/FGF-19	Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Gherlin secretion (evaluated by iAUC)	Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
C-peptide secretion (evaluated by iAUC)	Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
TSH/T3/T4	0, 60, 120, 180
GIP secretion (evaluated by iAUC)	Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
CCK secretion (evaluated by iAUC)	Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Glucagon secretion (evaluated by iAUC)	Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Appetite measurements (VAS-score)	Baseline, 30, 60, 120, 180

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark