Nonalcoholic Fatty Liver Disease Clinical Trial
— NAFLD-cohortOfficial title:
Disease Mechanisms and Markers for Non-alcoholic Steatohepatitis in a Population With Non-alcoholic Fatty Liver Disease: a Prospective Cohort Study With Biobank
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 2027 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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). - Not willing to be informed about unexpected findings by MRI - Unwilling to collect bio samples. - Pregnancy and breastfeeding. - Indication or planned for bariatric surgery within one year after inclusion or 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 or recovering from a surgical 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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Center | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | Centrum Obesitas-Eetstoornissen (CO-EUR) |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Development of NASH | 10 years | No | |
Secondary | Prevalence of hepatic complications of NAFLD | 10 years | No | |
Secondary | Prevalence of extrahepatic complications of NAFLD | 10 years | No |
Status | Clinical Trial | Phase | |
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