Bileacid Malabsorption and GLP-1 Secretion

University Hospital, Gentofte, Copenhagen

Status and phase: Completed; Phase 4

Conditions: Bileacid Malabsorption

Treatments: Drug: Placebos; Drug: "cholestagel®" (Colesevelam)

Study type: Interventional

Funder types: Other

Identifiers

NCT03009916

H-15004394

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups

Healthy controls

Other group

Description:

Healthy controls found according to the protocol

Treatment:

Drug: Placebos

Drug: "cholestagel®" (Colesevelam)

Patients with BAM

Other group

Description:

Patients with bile acid malabsorption found according to the protocol

Treatment:

Drug: Placebos

Drug: "cholestagel®" (Colesevelam)