Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT00509418
Eligibility Criteria:
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 mmol per liter)
* Contraindication to liver biopsy
* Refusal to participate in the study
* Concomitant disease with reduced life expectancy
* Severe psychiatric conditions
* Drug dependence
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00509418
Study Brief:
Protocol Section:
NCT00509418