Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis

Inclusion Criteria:

• Histological diagnosis of steatohepatitis (minimal histological criteria forsteatohepatitis include steatosis involving at least 5% of hepatocytes, lobularinflammation, 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 40g)

Exclusion Criteria:

• Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-inducedliver 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 channelblockers) and gastrointestinal bypass surgery

• Pharmacological treatment with some potential benefit on NAFL includingursodeoxycholic 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