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Clinical Trial Details

Trial ID: L4869
Source ID: NCT01666223
Associated Drug: Colesevelam
Title: Effect of Bile Acids on GLP-1 Secretion
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Obesity
Interventions: DRUG: Colesevelam|DRUG: Chenodeoxycholic Acid|OTHER: saline|DRUG: Colesevelam 3750 mg + chenodeoxycholic acid 1250 mg
Outcome Measures: Primary: Change in GLP-1, At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes | Secondary: Change in insulin, At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes|Change in C-peptide, At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes|Change in glucagon, At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes|Change in glucagon-like-peptide 2 (GLP-2), At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes|Change in glucose-dependent insulinotropic polypeptide (GIP), At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes|Change in peptide YY (PYY), At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes|Change in oxyntomodulin, At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes|Change in bile acids, At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes|Change in gastrin, At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes|Change in CCK, At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes|Change in appetite, satiety and prospective food consumption, Evaluated by Visual Analog Scale (VAS), At baseline, and 30, 60, 90, 120 and 180 minutes|Change in gallbladder volume, Evaluated by ultrasound, -30, 0 (baseline), 30, 60, 120 og 180 minutes|Change in basal metabolic rate, Evaluated by indirect calorimetry, At -30, 60 og 150 minutes|Change in bile acid composition, Evaluated by duodenal aspiration, At -30, 0, 30, 60, 120 og 180 minutes
Sponsor/Collaborators: Sponsor: University Hospital, Gentofte, Copenhagen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2012-11
Completion Date: 2013-06
Results First Posted:
Last Update Posted: 2013-12-24
Locations: Diabetes Research Division, Department of Internal Medicine, Gentofte Hospital, University of Copenhagen, Hellerup, Copenhagen, Denmark
URL: https://clinicaltrials.gov/show/NCT01666223