Following people with fatty liver disease to study its progression
Follows adults with fatty liver disease to study factors leading to a more serious form.
Plain-language title generated from the registry record
Registry title: Prospective Cohort, With Biobanking, of Patients With Nonalcoholic Fatty Liver Disease
Key facts
- Where
- Maastricht, NetherlandsSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT02422238, who can take part
Where in Netherlands
- Maastricht University Medical CenterMaastricht, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Maastricht University Medical Center
- Trial code
- NCT02422238
- Record updated
- 13 September 2016
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; 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; Indication or planned for bariatric surgery within one year after inclusion or a history of bariatric surgery; Incompetent to understand and/or sign the informed consent; 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; Diagnosis of liver cirrhosis and/or hepatocellular carcinoma.