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Clinical Trial Details

Trial ID: L4796
Source ID: NCT02445508
Associated Drug: Sevelamer
Title: Effect of Bile Acid Secretion and Sequestration on GLP-1 Secretion
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Sevelamer|DRUG: Cholecystokinin|DRUG: Sevelamer placebo|DRUG: Isotonic saline
Outcome Measures: Primary: Glucagon-like peptide-1 (GLP-1): Incremental and total area under the Concentration-Time Curve, Incremental and total area under the Concentration-Time Curve (AUC 0-240 min), -30, -15, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 min on study days 1-4 | Secondary: Responses of various other gut hormones: Incremental and total area under the Concentration-Time Curve, Incremental and total area under the Concentration-Time Curve (AUC 0-240 min), -30, -15, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 min on study days 1-4|Blood analysis of paracetamol as an assessment of gastric emptying, Assessment of gastric emptying, -30, -15, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 min on study days 1-4|Indirect calorimetry: Basal metabolic rate, Basal metabolic rate, -30 min to 240 min|Gallbladder volume as assessed by Ultrasound measurements, Gallbladder volume, -30 min to 240 min|Appetite as assessed by Visual analog scale score, Appetite, -30 min to 240 min
Sponsor/Collaborators: Sponsor: University Hospital, Gentofte, Copenhagen | Collaborators: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 15
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2015-05
Completion Date: 2016-07
Results First Posted:
Last Update Posted: 2017-05-03
Locations: Center for Diabetes Research, Hellerup, 2900, Denmark
URL: https://clinicaltrials.gov/show/NCT02445508