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 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT06220695
Eligibility Criteria:
Inclusion Criteria:
* Able to understand and sign informed consent
* BMI\> 25 kg/m2
* Between 18-80 years
* previous clinical diagnosis of MASLD by abdominal USG, MRI, FibroScan® or liver biopsy
Exclusion Criteria:
* Excessive alcohol use (more than 20 g/day for women and 30g/day for men= \>2 units alcohol/day for women and \>3 units for men)
* Other liver diseases: Hepatitis B virus, Hepatitis C virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, Alpha 1 antitrypsin deficiency
* Secondary causes for steatosis: disorders of lipid metabolism, HCV Genotype 3, total parental nutrition, severe surgical weight loss, medications (amiodarone, tamoxifen, methotrexate, corticosteroids and HAART)
* Celiac disease
* pregnancy and breastfeeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06220695
Study Brief:
Protocol Section:
NCT06220695