Bileacid Malabsorption and GLP-1 Secretion

Bileacid Malabsorption Clinical Trial

Official title:

Bileacid Malabsorption and GLP-1 Secretion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009916
• Other study ID #: H-15004394
• Status: Completed
• Phase: Phase 4
• First received: December 21, 2016
• Last updated: August 4, 2017
• Start date: March 2016
• Est. completion date: August 4, 2017

Study information

• Verified date: August 2017
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to examine the influence of BAM on postprandial GLP--1 secretion and glucose homeostasis, both with and without bile acid sequestration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 4, 2017
• Est. primary completion date: August 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Northern European origin

• Normal haemoglobin

• Age above 18 years and below 70 years

• Informed and written consent

• BMI > 23 kg/m2 and < 35 kg/m2

• Normal fasting plasma glucose (FPG) < 6.5 mM) and glycated haemoglobin (HbA1c) < 48 mmol/mol

Exclusion Criteria:

• Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder

• Gastrointestinal disease (except BAM), previous intestinal resection, cholecystectomy or any major intra-abdominal surgery

• First-degree relatives with diabetes

• Nephropathy (serum creatinine >150 µM and/or albuminuria

• Treatment with medicine that cannot be paused for 12 hours

• Hypothyroidism or hyperthyroidism

• Treatment with oral anticoagulants

• Active or recent malignant disease

• Any treatment or condition requiring acute or sub-acute medical or surgical intervention

• Lack of effective birth control in premenopausal women

• Any condition considered incompatible with participation by the investigators

Related Conditions & MeSH terms

• Bileacid Malabsorption
• Malabsorption Syndromes

Intervention

Drug:
• "cholestagel®" (Colesevelam)
3750mg
• Placebos
3750mg

Locations

Country	Name	City	State
Denmark	Center for Diabetes Research, Gentofte Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GLP-1		240 min