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Clinical Trial Details

Trial ID: L2063
Source ID: NCT02033876
Associated Drug: Ursodiol
Title: Ursodiol on Insulin Sensitivity, Gastric Emptying and Body Weight With Type 2 Diabetes on Metformin
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02033876/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Ursodiol
Outcome Measures: Primary: Change in Area Above Basal (AAB) for Glucose, Mixed meal glucose results are used to calculate the area above basal (AAB) for glucose. The glycemic index of a food is defined as the incremental area under the two-hour blood glucose response curve (AUC) following an overnight fast and ingestion of a food with a certain quantity of available carbohydrate (usually 50 g)., baseline, post-treatment approximately 14 - 17 days | Secondary: Change in Fasting Glucose, Serum glucose measurements taken after 10 hours of fasting., baseline, post-treatment approximately 14 - 17 days|Change in Insulin Sensitivity, Insulin sensitivity will be calculated by the oral minimal model., baseline, post-treatment approximately 14 - 17 days|Gastric Emptying of Liquids (T1/2), The time for half of the ingested liquids to leave the stomach. Following a meal with milk labeled with indium In111 diethylenetriaminepentaacetate (0.1 mCi), gastric emptying of liquids was assessed with scintigraphy imaging., post-treatment, approximately 14-17 days|Gastric Emptying of Solids (T1/2), The time for half of the ingested solids to leave the stomach. Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi) served with 50g of Canadian bacon and one slice of bread gastric emptying of solids was assessed with scintigraphy imaging., post-treatment, approximately 14-17 days|Change in Weight, Change in subject's weight, in kilograms, baseline, post-treatment approximately 14 - 17 days|Change in Body Mass Index, Change in subjects BMI, in kilograms per meter squared., baseline, post-treatment approximately 14 - 17 days|Change in FGF-19, Change in fasting fibroblast growth factor (FGF)-19 expression., baseline, post-treatment approximately 14 - 17 days
Sponsor/Collaborators: Sponsor: Mayo Clinic
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-10
Completion Date: 2017-03
Results First Posted: 2019-05-08
Last Update Posted: 2019-05-08
Locations: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States
URL: https://clinicaltrials.gov/show/NCT02033876