Status:
COMPLETED
Identification and Characterization of NAFLD in Turkey
Lead Sponsor:
Maastricht University
Collaborating Sponsors:
Pax Clinic
Conditions:
Non-Alcoholic Fatty Liver Disease
Liver Diseases
Eligibility:
All Genders
18-80 years
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...
Detailed Description
Non-alcoholic fatty liver disease (NAFLD), characterized with more than 5% intrahepatic fat accumulation in the absence of classical causes of steatogenesis, is considered as a growing epidemic with a...
Eligibility Criteria
Inclusion
- Able to understand and sign the informed consent
- Able to speak Turkish
- Between 18-80 years
- BMI \>25 kg/m²
- Having one of the following conditions: 1)Insulin resistance 2)Impaired glucose tolerence 3)type 2 diabetes mellitus, 4)hypertension 5)dyslipidemia 6)cardiovascular diseases (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 :
February 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2023
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT05194553
Start Date
February 15 2022
End Date
June 15 2023
Last Update
January 17 2024
Active Locations (1)
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1
Pax Clinic
Istanbul, Turkey (Türkiye)