Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
after food) is given to the control group.
Intervention1: Dapagliflozin: Dapagliflozin 10 mg once a day (Morning
after food) is given to the test group.
Control Intervention1: Saroglitazar: Saroglitazar 4 mg once a day (Morning, after food) is given to the control group.
Control Intervention2: Saroglitazar: Saro
Sponsors
SRM Medical College Hospital and Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: Willing participants with 1. Age greater than 18 years 2. Newly diagnosed or previously diagnosed with type 2 diabetes mellitus (According to American Diabetes Association, HbA1c greater than 6.5 percentage, FBS greater than 126 mg/dl, PPBS greater than 200 mg/dl) 3. Evidence of fatty liver on ultrasound 4. BMI greater than or equal to 25 kg/m2 or waist circumference greater than 94 cm in men and greater than 80 cm in women 5. No history of alcohol consumption
Exclusion criteria
Exclusion criteria: 1. Chronic hepatitis B or C 2. Individuals having type- 1 diabetes mellitus or individuals on insulin therapy 3. Drugs affecting MASLD such as vitamin E, pioglitazone, SGLT2 inhibitors, Saroglitazar and glucagon-like peptide 1 analogues 4. Patients on pharmacological or non-pharmacological treatment for weight loss and patients on intentional weight losing program 5. Liver diseases due to other etiologies like autoimmune liver disease, Wilsons disease etc., uncontrolled thyroid disease, active cardio-pulmonary disease or chronic kidney disease 6. Cirrhotic patients 7. Lactating and pregnant women 8. Patients who were known to have cardiac and renal disorders after medical history interview 9. History of mental illness or inability to cooperate with the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of Dapagliflozin in comparison with Saroglitazar. Reduction in FIB- 4 score.Timepoint: Baseline and at 12th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Improved Fatty liver index (FLI) score.Timepoint: Baseline & at 12th week;Reduction Controlled Attenuation Parameter (CAP) & Liver Stiffness Measurement (LSM).Timepoint: Baseline & at 12th week;Improvement in the metabolic parameters mentioned as follows: - 1. Anthropometric measurements- Height (cm), weight (kg), BMI (kg/m2), waist circumference (cm). 2. Blood glucose level- Fasting blood sugar (mg/dl), HbA1c (percentage). 3. Liver function test- Aspartate Aminotransferase/ Serum Glutamate-Oxaloacetate Transaminase (AST/SGOT) (U/L), Alanine Aminotransferase/ Serum Glutamate-Pyruvate Transaminase (ALT/SGPT) (U/L), Gamma-Glutamyl Transferase (GGT) (U/L). 4. Lipid profile- Low-density lipoprotein cholesterol (LDL-C) (mg/dl), High-density lipoprotein cholesterol (HDL-C) (mg/dl), Triglycerides (TG) (mg/dl)Timepoint: Baseline & at 12th week;Improved health related quality of life of patients measured by the validated CLDQ-NAFLD questionnairesTimepoint: Baseline & at 12th week;Adherence/compliance to the medications with follow-up every monthTimepoint: Baseline & at 12th week;Documenting the frequency of adverse events occurring during the study periodTimepoint: Baseline & at 12th week | — |
Countries
India
Contacts
Public ContactMs Pooja C
SRM Institute of Science and Technology
Outcome results
None listed