Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: TAB DAPAGLIFLOZIN 10MG: SGLT2 inhibitors like Dapagliflozin have shown beneficial effects on liver fat reduction, body weight, and glycemic indices in patients with type 2 diabetes and
Sponsors
No sponsor
Eligibility
Inclusion criteria
Inclusion criteria: A.Evidence of Hepatic Steatosis Confirmed through imaging techniques (such as ultrasound, CT, MRI) or histology (biopsy) and presence of at least 1 out of 5 Cardiometabolic Risk Factor. Cardiometabolic risk factors include- 1.Overweight/Obesity: BMI more than and equal to 25 kg/m (more than and equal to 23 kg/m for Asian populations), or waist circumference more than 94 cm (men) or more than 80 cm (women), with ethnicity-adjusted thresholds where applicable 2.Impaired Glucose Metabolism: Fasting glucose more than and equal to 100 mg/dL (5.6 mmol/L), 2-hour post-load glucose more than and equal to 140 mg/dL (7.8 mmol/L), HbA1c more than and equal to 5.7percent, or diagnosed type 2 diabetes mellitus (or its treatment) 3.Hypertension: Blood pressure more than and equal to 130/85 mmHg, or ongoing antihypertensive therapy 4.Hypertriglyceridemia: Triglycerides more than and equal to 150 mg/dL (1.70 mmol/L) or use of lipid-lowering therapy 5.Low HDL Cholesterol: HDL less than and equal to 40 mg/dL (men) or less than and equal to 50 mg/dL (women), or on lipid-lowering treatment B.Patient s willingness to comply with the study protocol and prior written informed consent
Exclusion criteria
Exclusion criteria: i) Patients with alternate causes of fatty liver including:- a) Patients on TPN and those who underwent surgical procedures within 90 days from randomization b) presence of other chronic liver disease such as hepatitis B or C, liver cirrhosis, Wilson s disease or any other autoimmune condition leading to fatty liver c) use of following drugs for more than 3 months over past 1 year before visit 1 including: Amiodarone, Tamoxifen, Methotrexate, Systemic glucocorticoids, Anabolic steroids, Tetracycline, Estrogen, Vitamin A, Asparagine, Valproate, Chloroquine, ARVs ii) Use of drugs with potential effect on MASLD such as: Ursodeoxycholic acid, S- Adenosyl Methionine(SAM-e), Betaine, Pentoxyfylline, Obeticholic acid, milk thistle, Vitamin E, statins, CYP3C8 inhibitors or substrate -within 3 months before visit 1 iii) Presence of bleeding disorders, myopathy, malignancy, hypothyroidism iv) Presence of anaemia, acute or chronic kidney disease, acute or chronic liver disease, heart failure v) Participant with body weight of more than 30kg/m2 vi)Participation in other MASLD/MASH related study within last 3 months vii) Pregnant or lactating females or couples planning pregnancy within 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum ALT levels from baseline to 24 weeks in MASLD patients receiving dapagliflozin 10 mg once daily or saroglitazar 4 mg once daily.Timepoint: Change in serum ALT levels from baseline to 24 weeks in MASLD patients receiving dapagliflozin 10 mg once daily or saroglitazar 4 mg once daily. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in CAP and LSM values (on FibroScan).Timepoint: At 12 and 24 weeks;Change in FIB-4 scoreTimepoint: At 12 and 24 weeks;Change in hepatic steatosis index.Timepoint: At 12 and 24 weeks;Change in AST:Platelet index.Timepoint: At 12 and 24 weeks;Change in blood pressureTimepoint: At 12 and 24 weeks;Change in serum lipid profile.Timepoint: At 12 and 24 weeks;Change in glucose metabolic parameters (HbA1c, fasting plasma glucose, HOMA-IR).Timepoint: At 12 and 24 weeks;Change in anthropometric parameters (body weight, BMI, waist/hip ratio).Timepoint: At 4, 12 and 24 weeks;Change in quality of life scores assessed by the Short-Form 36 Health Survey.Timepoint: At 24 weeks;Safety and tolerabilityTimepoint: At 24 weeks | — |
Countries
India
Contacts
Public ContactDr Nishi
Indira Gandhi Institute of Medical Sciences
Outcome results
None listed