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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT00655018
Eligibility Criteria:
Inclusion Criteria:
* persistently elevated serum aminotransferase levels,
* diffusely echogenic liver on imaging studies suggestive of fatty liver, and
* biopsy consistent with the diagnosis of NAFLD.
Exclusion Criteria:
* hepatic virus infections (HCV RNA-PCR negative),
* Hepatitis A, B, C, D, E and G,
* cytomegalovirus and Epstein-Barr virus,
* alcohol consumption,
* history of parenteral nutrition,
* and use of drugs known to induce steatosis (e.g. valproate, amiodarone or prednisone) or to affect body weight and carbohydrate metabolism.
* Autoimmune liver disease, metabolic liver disease, Wilson's disease, and a-1-antitrypsin-associated liver disease were ruled out using standard clinical, laboratory and histological criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
20 Years
Study:
NCT00655018
Study Brief:
Protocol Section:
NCT00655018