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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT00596934
Eligibility Criteria:
Inclusion Criteria:
* Biopsy proven NASH
* Circulating fasting leptin \<9 ng/mL (staggered criteria for different BMI levels)
Exclusion Criteria:
* Presence of advanced liver disease (as evidenced by abnormal synthetic function, abnormal prothrombin time or albumin)
* Presence of clinical lipodystrophy
* Presence of other liver disease
* Presence of clinical diabetes (fasting \>126 mg/dL or 2 hour post 75 g-glucose \>200 mg/dL or random glucose \>200 mg/dL with presence of diabetes symptoms or known history of diabetes)
* Any medication for treatment of NASH or obesity
* Presence of HIV
* Inability to give informed consent
* Presence of end-stage renal disease, any type of active cancer, or \>class 2 congestive heart failure ((New York Heart Association Functional Classification System), based on medical history and physical examination
* Presence of any other condition that limits life expectancy to \<2 years
* Active infection (may be transient)
* Any other condition in the opinion of the investigators that may impede successful data collection
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00596934
Study Brief:
Protocol Section:
NCT00596934