Bileacid Malabsorption and GLP-1 Secretion

Phase 4

Completed

• Conditions: Bileacid Malabsorption
• Interventions: Drug: "cholestagel®" (Colesevelam); Drug: Placebos

• Registration Number: NCT03009916
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2017-01-02
• Study First Posted: 2017-01-04
• Status Verified: 2017-08
• Primary Completion: 2017-08-03
• Study Completion: 2017-08-04
• Last Update Submitted: 2017-08-04
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Patients with BAM	"cholestagel®" (Colesevelam)	Patients with bile acid malabsorption found according to the protocol
Healthy controls	Placebos	Healthy controls found according to the protocol
Patients with BAM	Placebos	Patients with bile acid malabsorption found according to the protocol
Healthy controls	"cholestagel®" (Colesevelam)	Healthy controls found according to the protocol

Primary Outcome Measures

Name	Time	Method
GLP-1	240 min

Trial Locations

Locations (1)

Center for Diabetes Research, Gentofte Hospital; 🇩🇰 Hellerup, Denmark