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 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT04988204
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of NAFLD, defined by the presence of hepatic steatosis with vibration controlled transient elastography (VCTE) controlled attenuation parameter (CAP) measurement over 240dB/m, or liver biopsy showing macrovesicular steatosis in ≥ 5% of hepatocytes.
* patients were 18 years and older,
* fluent in English (the program could only be conducted in English by the DPP-certified coach),
* able to meet program scheduling requirements, and able to participate in physical activity.
Exclusion Criteria:
* additional causes of liver disease such as viral hepatitis, biliary obstruction, hepatocellular carcinoma, Wilson's disease, Budd Chiari Syndrome, autoimmune hepatitis, alcoholic liver disease or alcohol use (\>20g/day women, \>30g/day men),
* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values \>300 U/L,
* using steatogenic medications (amiodarone, methotrexate, tamoxifen, and corticosteroids),
* pregnant,
* a history of liver transplantation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04988204
Study Brief:
Protocol Section:
NCT04988204