A clinical study to compare the efficacy & safety of two drugs- Empagliflozin and Pioglitazone in Non alcoholic fatty liver disease patients with diabetes.
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2023/07/055756
- Lead Sponsor
- Delhi Pharmaceutical Sciences and Research University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Patient having age group 25 to 75 years with documented diagnosis of Diabetes (HbA1C > 6.5%) with NAFLD (findings suggested hepatic steatosis & hepatic dysfunction on clinical laboratory tests or on imaging studies (e.g., Computed Tomography (CT) or ultrasound) or Calculated fibrosis score by Fib-4 Score > 1.3, NAFLD-LFS score > 0.064 & APRI Score range 0.4 - 1.5).
1.Patient not willing to give consent form.
2.Patient with alcohol consumption.
3.Lactating & pregnant women.
4.Patient who already using drug such as SGLT-2 inhibitors, Pioglitazone, Insulin, GLP1Ra or drugs related with NAFLD for more than 12 sequential weeks before first visit in OPD.
5.Use of other drugs such as tamoxifen, methotrexate, amiodarone, systemic gluco-corticoids, tetracyclines, anabolic steroids, high doses of estrogens, oral contraceptives, L-asparaginase, sodium valproate, chloroquine & HIV-drugs.
6.Patient with serum positive Hepatitis-B surface antigen or anti-HCV & those who are contraindicated for SGLT-2 Inhibitors & Pioglitazone were excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Liver steatosis/ Fatty liver gradeTimepoint: After three months & six months
- Secondary Outcome Measures
Name Time Method Evaluating quality of life of Non alcoholic fatty liver disease patients with Diabetes MellitusTimepoint: 6 months;Monitoring safety by evaluating any adverse drug reactionsTimepoint: Follow up taken at every week;Prevalence of Non-alcoholic fatty liver disease patients in a tertiary care hospitalTimepoint: 3 months