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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT04918732
Eligibility Criteria:
Inclusion Criteria:
* Able to understand and sign the informed consent
* Able to speak Dutch
* Between 18-80 years
* BMI \>25 kg/m²
* Having one of the following conditions: 1)overweight, 2) obesity, 3) type 2 diabetes mellitus, 4) cardiovascular diseases (hypertension, atherosclerosis, angina pectoris, ischaemic heart condition, cerebrovascular condition)
Exclusion Criteria:
* Excessive alcohol use (more than 20 g/day for women and 30g/day for men= \>2 glasses alcohol/day for women and \>3 glasses 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), lean steatosis, Celiac disease, environmental toxicity
* Pregnancy and breastfeeding.
* A history of bariatric surgery.
* Diagnosis of liver cirrhosis and/or hepatocellular carcinoma.
* Current diagnosis of extrahepatic malignancy(s) or prior diagnosis within last 5 years.
* Individuals about to undergo a surgery or otherwise medical procedure that will interfere with data collection and analyses planned within the current cohort, will initially be excluded from participation, but are offered the opportunity to participate at a later moment in time (e.g., after 3 months are myocardial infarction patients are eligible for participation).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04918732
Study Brief:
Protocol Section:
NCT04918732