Overview

Bileacid Malabsorption and GLP-1 Secretion

Status:
Completed
Trial end date:
2017-08-04
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Treatments:
Colesevelam Hydrochloride
Criteria
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