Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis

Inclusion Criteria: * Histological diagnosis of steatohepatitis (minimal histological criteria for steatohepatitis include steatosis involving at least 5% of hepatocytes, lobular inflammation, and/or fibrosis) * Age between 18 and 70 years * Ability to provide informed consent * Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g) Exclusion Criteria: * Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and α-1 antitrypsin deficiency) * Pregnancy or lactation * Decompensated cirrhosis * Presence of secondary cause of NAFL such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass surgery * Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil * Fasting glucose levels greater than 250 mg per deciliter (13.3 mmolm per liter) * Contraindication to liver biopsy * Refusal to participate in the study * Concomitant disease with reduced life expectancy * Severe psychiatric conditions * Drug dependence