A clinical trial to compare the effectiveness of anti diabetic drug Dapagliflozin to that of Saroglitazar, a drug used in diabetic lipid (fat) disorders on the fat accumulation & scarring i.e. fibrosis of the liver in patients of type 2 diabetes mellitus with non-alcoholic fatty liver disease.
Not Applicable
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitusHealth Condition 2: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2023/06/053723
- Lead Sponsor
- Dr Bijay Ketan Das
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All patients meeting the diagnostic criteria for type 2 diabetes mellitus with non-alcoholic fatty liver disease
Exclusion Criteria
Patients with HbA1c > 9%
Patients with prior treatment with pioglitazone, saroglitazar or dapaglifzolin , VIT E, UDCA and obeticholic acid or agents known to induce steatosis (like valproate, amiodarone, oc pills or methotrexate) in the Past 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the CAP (controlled attenuated parameter) & LSM (liver stiffness measurement)Timepoint: Baseline <br/ ><br>12 weeks <br/ ><br>24 weeks <br/ ><br>52 weeks
- Secondary Outcome Measures
Name Time Method Change in weight, BMI & waist circumferenceTimepoint: Baseline <br/ ><br>12 weeks <br/ ><br>24 weeks <br/ ><br>52 weeks;Changes in the metabolic parameter (fasting lipid profile, fasting plasma glucose, 2hr post prandial blood sugar, HbA1c )Timepoint: Baseline <br/ ><br>12 weeks <br/ ><br>24 weeks <br/ ><br>52 weeks;Changes in the NAFLD fibrosis scores & FIB-4 scores.Timepoint: Baseline <br/ ><br>12 weeks <br/ ><br>24 weeks <br/ ><br>52 weeks