Prospective Cohort, With Biobanking, of Patients With Nonalcoholic Fatty Liver Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMaastricht University Medical Center

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Development of NASH

Time frame
10 years

Secondary outcomes

1

Prevalence of hepatic complications of NAFLD

Time frame
10 years
2

Prevalence of extrahepatic complications of NAFLD

Time frame
10 years

Other outcomes

Sponsors and contacts

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Maastricht University Medical Center

Lead sponsor

Centrum Obesitas-Eetstoornissen (CO-EUR)

Collaborator