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 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT04141592
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Confirmed non-alcoholic Fatty liver disease (diagnosed clinically, radiologically or histologically)
* If diabetic, Diagnosed with Type 2 Diabetes Mellitus
OR
• Healthy Control: no diagnosis of any liver condition including NAFLD
o NAFLD excluded by Fibroscan Controlled Attenuation Parameter (CAP) score of \<222 dB/m
Exclusion Criteria:
* Unwilling or unable to give informed consent
* Type 1 Diabetes Mellitus
* Other form of liver disease (other than NAFLD)
o Viral hepatitis, Auto-immune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, haemochromatosis, Sarcoidosis, cystic fibrosis, sickle cell disease
* Taking medication associated with liver dysfunction (except methotrexate)
* Auto-immune disease which in the investigator's opinion may confound immune profiling
* Concomitant immunosuppressive medications (except methotrexate, short course oral steroids or inhaled corticosteroids)
* Currently pregnant
* Any major organ transplant (excluding corneal or hair transplant)
* Regular alcohol intake greater than 14 units a week for female participants and 21 units a week for male participants
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04141592
Study Brief:
Protocol Section:
NCT04141592