About this trial
The aim of the present prospective NAFLD cohort study (with biobank), of obese subjects with proven NAFLD based on liver biopsy and/or MRI, is to study factors contributing to the development of NASH in patients with simple steatosis and to identify and validate non-invasive markers for the diagnosis of NASH.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
NAFLD diagnosis based on evidence of hepatic steatosis, either by imaging (using MRI) or by histology.
BMI ≥ 30 kg/m2
Between 18 - 65 years of age
Disqualifiers
Incompetent to understand and/or sign the informed consent.
Causes for secondary hepatic fat accumulation such as significant alcohol consumption, medications, Wilson's disease, viral infections, starvation or parenteral nutrition, among others, and conditions associated with microvesicular steatosis
Ethanol consumption exceeding more than 14 standard beverages per week for males and more than 7 standard beverages per week for female.
Not able or willing to undergo MRI (for example claustrophobia, ICD, pacemaker).
Trial population
Obese ( BMI ≥ 30 kg/m2) subjects with proven NAFLD either by imaging (using MRI) or histology, referred to secondary or tertiary care for obesity related problems will be asked to participate in this study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Development of NASH
Secondary outcomes
Prevalence of hepatic complications of NAFLD
Prevalence of extrahepatic complications of NAFLD
Sponsors and contacts
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Maastricht University Medical Center
Lead sponsor
Centrum Obesitas-Eetstoornissen (CO-EUR)
Collaborator