Comparative Clinical Study Between Empagliflozin Versus Pioglitazone in Non-diabetic Patients With Non-alcoholic Steatohepatitis

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate the possible beneficial effect of empagliflozin versus pioglitazone on non-diabetic patients with non-alcoholic steatohepatitis (NASH).

This study will be a randomized, comparative parallel study. The study will be conducted according to the ethical standards of Helsinki declaration in 1964 and its later amendments.

The study duration will be 24 weeks. The patients will be randomized into two groups:

Group 1: (Pioglitazone group; n=28) which will receive 30mg/day pioglitazone for 24 weeks.

Group 2: (Empagliflozin group; n=28) which will receive 10mg/day empagliflozin for 24 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanta University
• Treatments: Empagliflozin; Pioglitazone

Criteria

Inclusion Criteria:

• Non-diabetic patients.

• Both males and females.

• Age >18 years old.

• Patient with body mass index (BMI) > 30 kg/m2.

• Patients with established diagnosis of NASH based on liver ultrasonography, mild to moderate elevation in aminotransferase activities (>2 but <5 times upper limit of normal), hepatic steatosis index (HSI) >36, and HAIR score of 2 or 3.

Exclusion Criteria:

• Patients with BMI > 40 kg/m2.

• Patients with type 2 diabetes mellitus (T2DM) on the basis of a fasting plasma glucose (FPG) level ≥ 126 mg/dl (7mmol/L) or glycated hemoglobin (HbA1c) > 6.5% (48 mmol/mol).

• Alcohol consumption greater than 20 g per day for women or greater than 30 g for men for at least three consecutive months over the past 5 years.

• History of viral hepatitis, hemochromatosis, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, biliary obstruction, alpha-1 antitrypsin deficiency.

• Patients on medications interfere with lipid and carbohydrate metabolisms.

• Patients with heart failure (New York Heart Association (NYHA) class 2-4).

• Patients with history of cardiovascular events within the past 3 months.

• Patients with renal impairment (eGFR> 45 mL/min/ 1.73 m2).

• Patients with cancer or with a history of cancer treatment over the past 2 years.

• Patients with thyroid disorder.

• Patients on medications associated with steatosis such as Non-steroidal anti-inflammatory drugs (NSAIDs), amiodarone, tamoxifen, estrogen, sodium valproate, corticosteroids, and methotrexate.

• Patients with inflammatory diseases.

• Patients on supplements known to have antioxidant activity such as vitamin E, vitamin C, zinc, and selenium.

• Pregnant and breastfeeding women.

• Females on oral contraceptive pills will be also excluded.