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Clinical Trial Details

Trial ID: L6649
Source ID: NCT04642261
Associated Drug: Empagliflozin 10 Mg
Title: Effect of Empagliflozin on Liver Fat in Non-diabetic Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Non-alcoholic Fatty Liver Disease
Interventions: DRUG: Empagliflozin 10 MG|DRUG: Placebo pills
Outcome Measures: Primary: Change in liver fat content, Difference in the change of liver fat content between the two groups at week 52 from the baseline as measured by MRI-PDFF, week 52 | Secondary: Remission of steatosis, Remission of steatosis (defined as MRI-PDFF \< 5%) at week 52, week 52|Change of liver fat content, Difference in the change of liver fat content between the two groups at week 26 and 52 from the baseline (CAP measured by transient elastography), week 26 and 52|Changes of alanine aminotransferase (ALT), Changes of ALT at week 52, week 52|Changes of aspartate aminotransferase (AST), Changes of AST at week 52, week 52|Changes of alkaline phosphatase (ALP), Changes of ALP at week 52, week 52|Changes of gamma glutamyl transferase (GGT), Changes of GGT at week 52, week 52|Changes of fasting glucose, Changes of fasting glucose at week 52, week 52|Changes of haemoglobin A1c (HbA1c), Changes of HbA1c at week 52, week 52|Changes of total cholesterol, Changes of total cholesterol at week 52, week 52|Changes of low density lipoprotein (LDL), Changes of LDL at week 52, week 52|Changes of high density lipoprotein (HDL), Changes of HDL at week 52, week 52|Changes of body weight, Changes of body weight at week 52, week 52|Changes of height, Changes of height at week 52, week 52|Changes of body mass index (BMI), Changes of BMI at week 52, week 52|Changes of waist circumference, Changes of waist circumference at week 52, week 52|Changes of systolic blood pressure, Changes of systolic blood pressure at week 52, week 52|Changes of diastolic blood pressure, Changes of diastolic blood pressure at week 52, week 52
Sponsor/Collaborators: Sponsor: The University of Hong Kong | Collaborators: Food and Health Bureau, Hong Kong
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 98
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-01-01
Completion Date: 2023-06-30
Results First Posted:
Last Update Posted: 2023-12-07
Locations: The University of Hong Kong/Queen Mary Hospital, Hong Kong, Hong Kong, China, 852, Hong Kong
URL: https://clinicaltrials.gov/show/NCT04642261