Cohort of obese 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
This study is trying to find out what causes some obese people with fatty liver disease to develop a more serious condition and to see if there are easier ways to diagnose it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT02422238 on ClinicalTrials.gov |
What this trial studies
This prospective cohort study focuses on obese individuals diagnosed with nonalcoholic fatty liver disease (NAFLD) through liver biopsy or MRI. It aims to investigate the factors that contribute to the progression from simple steatosis to nonalcoholic steatohepatitis (NASH) and to identify non-invasive diagnostic markers for NASH. Participants will complete various questionnaires and undergo multiple assessments, including blood and urine tests, fibroscan, and DEXA-scan, over a period of 5 to 10 years. The study will help in understanding the disease's progression and potential therapeutic options.
Who should consider this trial
Good fit: Ideal candidates are obese individuals aged 18-65 with a confirmed diagnosis of NAFLD.
Not a fit: Patients with secondary causes of hepatic fat accumulation or those with liver cirrhosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and better management of NASH, reducing the risk of severe liver complications.
How similar studies have performed: Other studies have shown promise in identifying non-invasive markers for liver diseases, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Maastricht, Limburg
- Maastricht University Medical Center — Maastricht, Limburg, Netherlands (Recruiting)
Study contacts
- Study coordinator: Koek, MD, PhD
- Phone: 0031-43-3875021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.