| Trial ID: | L0113 |
| 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: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Diabetes Mellitus, Type 2|NASH - Nonalcoholic Steatohepatitis|NAFLD
|
| Interventions: |
Drug: Pioglitazone|Drug: Empagliflozin|Drug: Pioglitazone + Empagliflozin
|
| Outcome Measures: |
Change in radiologic liver parameters|Change in liver enzymes|Change in Fibrosis-4 (FIB-4) Score and NAFLD Fibrosis Score|Change in body weight|Change in waist circumference (WC)|Change in liver fat mass with total body fat (TBF)|Change in HbA1C levels (< 7.0%)|Change in Fasting Blood Sugar (FBS)|Change in Lipid profile
|
| Sponsor/Collaborators: |
Getz Pharma
|
| Gender: |
All
|
| Age: |
18 Years to 60 Years ?? (Adult)
|
| Phases: |
Phase 4
|
| Enrollment: |
123
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
September 15, 2021
|
| Completion Date: |
November 15, 2023
|
| Results First Posted: |
--
|
| Last Update Posted: |
March 18, 2022
|
| Locations: |
Aga Khan University Hospital, Karachi, Sindh, Pakistan
|
| URL: |
https://ClinicalTrials.gov/show/NCT04976283
|
