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:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT02526732
Eligibility Criteria:
Inclusion Criteria:
* histologically proven NASH or fatty liver disease
Exclusion Criteria:
* bariatric surgery within the last 5 years
* BMI\< 18,5 kg/m2 or \> 45 kg/m2
* heart attack or stroke within the last 6 months
* higher-grade coronary artery disease (CAD III-IV)
* chronic obstructive pulmonary disease (asthma , COPD)
* renal insufficiency
* uncontrolled hypertension or metabolic abnormalities
* alcohol consumption \> 30 g / day (male) and \> 20 g / day (female)
* pregnancy
* concomitant medication able to cause a secondary NASH (eg tamoxifen , corticosteroids )
* concomitant medication able to affect inflammation (eg TNF antagonists)
* concomitant anticoagulant medication (eg phenprocoumon, NOAC)
* other immunological or inflammatory diseases (eg, systemic lupus erythematosus)
* musculoskeletal disorders, preventing sport physiological investigations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02526732
Study Brief:
Protocol Section:
NCT02526732