Non Alcoholic Steatohepatitis Clinical Trial
Official title:
Comparative Clinical Study to Evaluate the Possible Beneficial Effect of Empagliflozin Versus Pioglitazone on Non-diabetic Patients With Non-Alcoholic Steatohepatitis
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.
Status | Not yet recruiting |
Enrollment | 56 |
Est. completion date | November 2024 |
Est. primary completion date | May 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
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Egypt | Tanta University | Tanta | Gharbiya |
Lead Sponsor | Collaborator |
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Tanta University |
Egypt,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in fibrosis index based on the 4 factors (FIB-4) | FIB-4 will be calculated using the formula: FIB-4 = Age (years)× AST (IU/L)/[platelet count (109/L) × ALT1/2 (IU/L)]. | Baseline and 24th week | |
Primary | Change in aspartate transaminase-to-platelet ratio index (APRI) | APRI will be calculated using the formula: APRI = (AST (IU/L)/upper limit of normal AST range) X 100 /platelet count (109/L). | Baseline and 24th week | |
Primary | Change in liver enzymes | Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and Gamma-glutamyl transferase (GGT) will be determined by kinetic method. | Baseline, 12th and 24th week | |
Secondary | Cytokeratin-18 (CK-18) | Serum level of cytokeratin-18 (CK-18) will be determined by Enzyme-linked Immunosorbent assay kits. | Baseline and 24th week | |
Secondary | Malondialdehyde (MDA) | Serum level of Malondialdehyde (MDA) will be assessed by colorimetric method. | Baseline and 24th week | |
Secondary | Tumor necrosis factor-alpha (TNF-a) | Serum levels of Tumor necrosis factor-alpha (TNF-a) will be determined by Enzyme-linked Immunosorbent assay kits. | Baseline and 24th week | |
Secondary | Transforming growth factor-beta1 (TGF-ß1) | Serum levels of Transforming growth factor-beta1 (TGF-ß1) will be determined by Enzyme-linked Immunosrbent assay kits. | Baseline and 24th week |
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