NCT02422238Recruiting
Prospective Cohort, With Biobanking, of Patients With Nonalcoholic Fatty Liver Disease
Disease Mechanisms and Markers for Non-alcoholic Steatohepatitis in a Population With Non-alcoholic Fatty Liver Disease: a Prospective Cohort Study With Biobank
Source: ClinicalTrials.gov · Last updated 13 Sept 2016 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 16 Apr 2015
- Start date
- Jun 2015
- Primary completion date
- Dec 2017
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT02422238
What you commit to
- Study type: Observational
- Planned participants: 500
- From Jun 2015 to the primary completion date, Dec 2017
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht University Medical Center Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.