Efficacy and Safety of Dapagliflozin in Patients With Non-alcoholic Steatohepatitis
Non-alcoholic Steatohepatitis
About this trial
This is an interventional treatment trial for Non-alcoholic Steatohepatitis focused on measuring Dapagliflozin, SGLT2 inhibitors, NASH, Efficacy, Safety, Liver biopsy, Pioglitazone, Fatty Liver, NAFLD activity score
Eligibility Criteria
Inclusion Criteria:
- Age range 18-65 years.
- Liver biopsy confirming NASH within 6 months.
- For diabetic patients, the patients should be with stable glycemic control defined as HbA1C <10%.
Exclusion Criteria:
- Active viral hepatitis (HBV, HCV).
- Child Pugh B or C cirrhosis.
- Alcohol consumption in the past six months.
- A history of alcoholic liver disease.
- Secondary causes of steatohepatitis.
- Autoimmune hepatitis.
- Celiac disease.
- Hemochromatosis or Wilson's disease.
- Drug induced liver injury (DILI) or patient with history of taking medication(s) that may cause fatty liver (e.g., tamoxifen, valproic acid, amiodarone, methotrexate, steroids, oral contraceptives).
- Obstructive biliary disease.
- Serum alanine aminotransferase (ALT) more than 2.5 folds of UNL.
- History of serious hypersensitivity to dapagliflozin or pioglitazone or any component of the formulation.
- Pregnancy and breastfeeding.
- Renal impairment (eGFR <45 mL/minute/1.73 m2), end-stage renal disease (ESRD), or patients on dialysis.
- Having any medical condition that would affect metabolism (i.e., known hyperthyroidism or hypothyroidism).
- Hypopituitarism.
- Patients with Type 1 diabetes.
- Starvation.
- Serious medical disease with likely life expectancy less than 5 years.
- Participation in other clinical trial in the 30 days before enrollment.
- Patients who are unwilling or unable to give informed consent.
- Patients on statins.
- Heart failure defined as New York Heart Association (NYHA) class III or IV.
- Recent initiation or change of antidiabetic drugs that influence liver fat including thiazolidinediones, glucagon like peptide 1 receptor agonists or any SGLT2 inhibitor.
Sites / Locations
- National Hepatology and Tropical Medicine Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Active Comparator
Diabetic Group 1
Diabetic Group 2
Non-diabetic Group 1
Non-diabetic Group 2
25 diabetic patients will be prescribed on dapagliflozin 10 mg - once daily (OD) - to be taken orally (PO) for 24 weeks
25 diabetic patients will be prescribed on Pioglitazone 30 mg - once daily (OD) - to be taken orally (PO) for 24 weeks
25 non-diabetic patients will be prescribed on dapagliflozin 10 mg - once daily (OD) - to be taken orally (PO) for 24 weeks.
25 non-diabetic patients will be prescribed on Pioglitazone 30 mg - once daily (OD) - to be taken orally (PO) for 24 weeks