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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT01472120
Eligibility Criteria:
Inclusion Criteria:
* Persistently (at least 6 months) elevated aminotransferases
* Ultrasonographic presence of bright liver without any other liver or biliary tract disease
* Liver histology compatible with a diagnosis of NASH or SS
Exclusion Criteria:
* A history of alcohol consumption \>40 g/wk, as assessed by a detailed interview extended to family members
* Morbid obesity \[body mass index (BMI) ≥40 kg/m2\], hypertension
* Positive blood markers of viral, autoimmune, or celiac disease
* Abnormal copper metabolism or thyroid function tests
* A diagnosis of T2DM and systemic arterial hypertension
* Total cholesterol (TC) ≥250 mg/dL, triglycerides (TG) ≥400 mg/dL, exposure to occupational hepatotoxins or drugs known to affect glucose and lipid metabolism
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT01472120
Study Brief:
Protocol Section:
NCT01472120