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

Severe Obesity Clinical Trial

Official title:

Effects of Chenodeoxycholic Acid and Colesevelam on GLP-1 Secretion, During a Meal, After Roux-en-Y Gastric Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876484
• Other study ID #: IJ-G2-16
• Status: Completed
• Phase: Phase 4
• Start date: June 2016
• Est. completion date: November 2020

Study information

• Verified date: November 2020
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2020
• Est. primary completion date: June 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 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

Related Conditions & MeSH terms

• Obesity, Morbid
• Severe Obesity

Intervention

Drug:
• Colesevelam

• Chenodeoxycholic Acid

Other:
• Water

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