A Comparitive study of Dapagliflozin Vs Pioglitazone in Patients of Non Alcoholic Fatty liver disease with Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Achieving the target level of HbA1C 6.5%
Study Overview
Brief Summary
TITLE: A COMPARATIVE STUDY OF DAPAGLIFLOZIN VS PIOGLITAZONE IN PATIENTS OF NON ALCOHOLIC FATTY LIVER DISEASE WITH TYPE 2 DIABETES MELLITUS BACKGROUND: NAFLD Is a condition in which excess fat builds up in the liver.This buildup of fat is not caused by heavy alcohol use. DAPAGLIFLOZIN An inhibitor of sodium-glucose co-transporter 2 (SGLT2),decreases blood glucose levels without the use of insulin by improving renal glucose excretion. PIOGLITAZONE Is an oral drug It works by stimulating nuclear receptors known as peroxisome proliferator-activated receptor gamma(PPAR-γ) and modifies gene expression through binding to PPAR-γ, which has several consequences. MATERIAL AND METHODS: The study employed a prospective, randomized, open-label design and was conducted at ERA’S Lucknow Medical College & Hospital, with collaboration from the Department of Pharmacology, Medicine, and Radiology. It involved a total sample size of 108 patients, evenly distributed with 54 patients in each group. The study continued for a duration of 18 months
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
Achieving the target level of HbA1C 6.5%
Time Frame: 3 week 6 week 12 week
Secondary Outcomes
- Secondary Outcome:(• Assessment of glycemic control (HbA1c) in participants.)
Investigators
Babra
Eras Lucknow Medical College