Bileacid Malabsorption
Conditions
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.
Interventions
DRUGcholestagel® (Colesevelam)
3750mg
DRUGPlacebos
3750mg
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GLP-1 | 240 min |
Countries
Denmark
Outcome results
None listed