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Clinical Trial Details

Trial ID: L3161
Source ID: NCT03068065
Associated Drug: Liraglutide
Title: Antidiabetic Effects on Intrahepatic Fat
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Non-Alcoholic Fatty Liver Disease|Type2 Diabetes
Interventions: DRUG: Liraglutide|DRUG: Metformin|DRUG: Gliclazide
Outcome Measures: Primary: Intrahepatic fat, intrahepatic fat change from baseline by quantitative ultrasound, -7±3days; 168±3days | Secondary: Liver function, serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST), -7±3days; 28±3days; 84±3days; 168±3days|Lipid, total cholesterol (CH), triglyceride (TG), high-density lipoprotein cholesterol (HDL), and low-density lipoprotein cholesterol (LDL), -7±3days; 28±3days; 84±3days; 168±3days|Plasma glucose in standard meal tolerance test, plasma glucose was measured at 0, 30, 60, and 120 min after ingestion of the meal, -7±3days; 168±3days|Plasma insulin in standard meal tolerance test, plasma insulin was measured at 0, 30, 60, and 120 min after ingestion of the meal, -7±3days; 168±3days|Glucose control, fasting blood glucose (FBG), postprandial blood glucose (PBG), 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days|HbA1c, glycosylated hemoglobin A 1c (HbA1c) was measured by high-performance liquid chromatography, -7±3days; 84±3days; 168±3days|Body composition, fat mass and lean tissue were measured by dual-energy X-ray absorptiometry, -7±3days; 168±3days|Weight, body weight, 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days|WC, waist circumference, 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days | Other: Number of Participants with gliclazide, liraglutide or metformin adverse events as a measure of safety and tolerability, adverse events caused by the drugs, -7±3days; 0±3days; 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3day;168±3days
Sponsor/Collaborators: Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 87
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-05
Completion Date: 2015-10
Results First Posted:
Last Update Posted: 2017-03-01
Locations: at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University, Nanjing, Jiangsu, 210008, China
URL: https://clinicaltrials.gov/show/NCT03068065