Clinical Trial Details
| Trial ID: | L6679 |
| Source ID: | NCT04910178 |
| Associated Drug: | Empagliflozin 25 Mg |
| Title: | Follow-up of NAFLD Patients With MRI-PDFF |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Type 2|NAFLD |
| Interventions: | DRUG: Empagliflozin 25 MG|DRUG: Ursodeoxycholic acid|DRUG: Pentoxifylline 400 MG|OTHER: placebo |
| Outcome Measures: | Primary: liver fat content (percent), measured by MRI-PDFF, 6-months|fatty liver staging (0, I, II, and III), using ultrasound, 6-months | Secondary: Changes in Serum Gamma glutamyl transferase (γ-GT), IU/l, 6-months|HbA1c (%), 6-months|Fasting and 2-hr post-prandial serum glucose (mg/dl), 6-months|Lipid profile, (serum triglycerides, total cholesterol, LDL, HDL) (mg/dl), 6-months|Changes in liver enzymes, AST (IU/l) and ALT (IU/l), 6-months|Changes in direct and total bilirubin, (mg/dl), 6-months|Changes in total protein and albumin, (g/l), 6-months |
| Sponsor/Collaborators: | Sponsor: Asmaa Abdelfattah Elsayed |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 80 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2020-12-01 |
| Completion Date: | 2021-12-30 |
| Results First Posted: | |
| Last Update Posted: | 2022-12-20 |
| Locations: | Minya University Hospital, Minya, 61118, Egypt |
| URL: | https://clinicaltrials.gov/show/NCT04910178 |
