Lead Sponsor

Catalysis SL

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

No

•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)

•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 mmol per liter)
•Contraindication to liver biopsy
•Refusal to participate in the study
•Concomitant disease with reduced life expectancy
•Severe psychiatric conditions
•Drug dependence

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