Status:
RECRUITING
NAFLD Primary Care
Lead Sponsor:
Maastricht University
Conditions:
Non-Alcoholic Fatty Liver Disease
Cardiovascular Diseases
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) is with 25% the most prevalent liver disorder in Western society and is associated with overweight, obesity, metabolic syndrome (MetS), type 2 diabetes mellit...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
1470 Patients enrolled
Trial Details
Trial ID
NCT04918732
Start Date
May 5 2021
End Date
December 31 2024
Last Update
April 15 2024
Active Locations (1)
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1
Maastricht University
Maastricht, Limburg, Netherlands