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Clinical Trial Details

Trial ID: L6473
Source ID: NCT04976283
Associated Drug: Pioglitazone
Title: Effect of Oral Anti-diabetic Medication on Liver Fat in Subjects With Type II Diabetes and Non-alcoholic Fatty Liver
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|NASH - Nonalcoholic Steatohepatitis|NAFLD
Interventions: DRUG: Pioglitazone|DRUG: Empagliflozin|DRUG: Pioglitazone + Empagliflozin
Outcome Measures: Primary: Change in radiologic liver parameters, Number of participants reported change in liver fat content from baseline, as quantified by fibroscan, 12 months | Secondary: Change in liver enzymes, Number of participants reported change in liver enzymes levels including ALT, AST and GGT, 12 months|Change in Fibrosis-4 (FIB-4) Score and NAFLD Fibrosis Score, Number of participants reported change in FIB-4 Score and NAFLD Fibrosis Score. Fibrosis-4 scores range from 0 to 4, where \<1.45 indicates absence of cirrhosis; score between 1.45 - 3.25 are deemed inconclusive and score \>3.25 indicates cirrhosis., 12 months|Change in body weight, Number of participants reported change in body weight from baseline (treat to target response of at least 5% of baseline at 6 months, 10% baseline over 12 months)., 12 months|Change in waist circumference (WC), Number of participants reported change in waist circumference (WC), 12 months|Change in liver fat mass with total body fat (TBF), Comparison of baseline and end of treatment liver fat mass with total body fat (TBF) using a Body Composition Monitor, 12 months|Change in HbA1C levels (< 7.0%), Number of participants reported change in HbA1C levels from baseline to end of treatment, 12 months|Change in Fasting Blood Sugar (FBS), Number of participants reported change in Fasting Blood Sugar (FBS) from baseline to end of treatment, 12 months|Change in Lipid profile, Number of participants reported change in Fasting triglycerides (TG), Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL) from baseline to end of treatment, 12 months | Other: Change in Urine Albumin to Creatinine Ratio (UACR), Number of participants reported change in Urine Albumin to Creatinine Ratio (UACR) from baseline to end of treatment, 12 months|Change in Systolic and Diastolic blood pressure, Number of participants reported change in Systolic and Diastolic blood pressure from baseline to end of treatment, 12 months
Sponsor/Collaborators: Sponsor: Getz Pharma
Gender: ALL
Age: ADULT
Phases: PHASE4
Enrollment: 123
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-09-15
Completion Date: 2023-11-15
Results First Posted:
Last Update Posted: 2022-03-18
Locations: Aga Khan University Hospital, Karachi, Sindh, 74800, Pakistan
URL: https://clinicaltrials.gov/show/NCT04976283