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Clinical Trial Details

Trial ID: L3318
Source ID: NCT02061124
Associated Drug: Sevelamer 1600 Mg Tid For 7 Days
Title: Effect of Bile Acid Sequestration on Postprandial GLP-1 Secretion, Glucose Homeostasis and Gut Microbiota
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Sevelamer 1600 mg TID for 7 days|DRUG: Placebo 1600 mg TID for 7 days
Outcome Measures: Primary: Incremental and total area under the Concentration-Time Curve (AUC 0-240 min), Postprandial responses of glucagon-like peptide-1 (GLP-1), -30, -15, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 min on study days 1 and 7 (meal tests start at 0 min) | Secondary: Incremental and total area under the Concentration-Time Curve (AUC 0-240 min), Postprandial responses of various other gut hormones, -30, -15, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 min on study days 1 and 7 (meal tests start at 0 min) | Other: Blood analysis, Lipids, Fasting status on study days 1 and 7|Blood analysis, Inflammatory and metabolic markers, Fasting status on study days 1 and 7|Faecal samples, Gut microbiota composition, Prior to study days 1 and 7|Blood analysis of paracetamol, Assessment of gastric emptying, -30 min to 240 min (ingestion of meal at 0 min) on study days 1 and 7|Bodyweight, Fasting state on study days 1 and 7|Indirect calorimetry, Basal metabolic rate, -30 min to 240 min (ingestion of meal at 0 min) on study days 1 and 7|Ultrasound measurements, Gall bladder volume, -30 min to 240 min (ingestion of meal at 0 min) on study days 1 and 7|Visual analog scale score, Appetite, -30 min to 240 min (ingestion of meal at 0 min) on study days 1 and 7
Sponsor/Collaborators: Sponsor: University Hospital, Gentofte, Copenhagen | Collaborators: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 50
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2014-02
Completion Date: 2015-10
Results First Posted:
Last Update Posted: 2015-11-23
Locations: Diabetes Research Division, Gentofte Hospital, Copenhagen, Hellerup, 2900, Denmark
URL: https://clinicaltrials.gov/show/NCT02061124