Comparison of Dapagliflozin and Pioglitazone for Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes
Phase 4
- Conditions
- Health Condition 1: K760- Fatty (change of) liver, not elsewhere classifiedHealth Condition 2: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2024/07/071087
- Lead Sponsor
- Babra
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1 NAFLD Fibrosis Score(Stage 1 to Stage 3)
2 USG (Grade 2 & Grade 3 fatty liver)
3 HbA1C 6.5% & above
4 BMI 23 kg/m² & above
5 Type 2 diabetes mellitus patient on treatment of metformin (upto 2g/day)
Exclusion Criteria
1 Patient with heart failure, kidney failure, malignancy
2 Pregnant & Lactating mothers
3 Habitual drinkers
4 Contraindication to dapagliflozin and pioglitazone
5 Use of steroid &/ or other immunosuppressor
6 H/o mental illness or inability to co operate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Achieving the target level of HbA1C 6.5% <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 3 week 6 week 12 week <br/ ><br> <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Secondary Outcome: <br/ ><br>•Assessment of glycemic control (HbA1c) in participants. <br/ ><br>•Adverse events of Dapagliflozin and Pioglitazone in study population. <br/ ><br>Timepoint: 3,6,12th week