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

Severe Obesity Clinical Trial

Official title:

Effects of Ursodeoxycholic Acid and Chenodeoxycholic Acid on GLP-1 Secretion After Roux-en-Y Gastric Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340247
• Other study ID #: SN-GALDE-14
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2015
• Last updated: June 29, 2016
• Start date: November 2014

Study information

• Verified date: June 2016
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity, Morbid
• Severe Obesity

Intervention

Other:
• Water

Drug:
• Ursodeoxycholic Acid

• Chenodeoxycholic Acid

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

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)		Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180	No
Secondary	C-peptide secretion (evaluated by iAUC)		Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180	No
Secondary	PYY secretion (evaluated by iAUC)		Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180	No
Secondary	Glucagon secretion (evaluated by iAUC)		Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180	No
Secondary	GIP secretion (evaluated by iAUC)		Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180	No
Secondary	CCK secretion (evaluated by iAUC)		Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180	No
Secondary	Gherlin secretion (evaluated by iAUC)		Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180	No
Secondary	Changes in bile acids/FGF-19		Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180	No
Secondary	TSH/T3/T4		0, 60, 120, 180	No
Secondary	Appetite measurements (VAS-score)		Baseline, 30, 60, 120, 180	No