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

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Apr 16, 2015

Keywords

ClinConnect Summary

This clinical trial is looking at patients with Nonalcoholic Fatty Liver Disease (NAFLD), a condition where fat builds up in the liver without excessive alcohol consumption. The goal of the study is to understand what factors lead to a more serious form of the disease called Nonalcoholic Steatohepatitis (NASH) and to find easier ways to diagnose NASH without invasive procedures like liver biopsies. The researchers will collect information from participants, including samples of blood and tissue, to help in their investigation.

To be eligible for the study, participants must be between 18 and 65 years old, have a body mass index (BMI) of 30 or higher, and have a confirmed diagnosis of NAFLD through imaging tests like MRI or from liver biopsy results. Participants who are pregnant, have certain medical conditions, or have a history of alcohol abuse are excluded. Those who join the trial can expect to undergo some tests, provide samples, and receive updates about their health based on the MRI results. This research is important because it aims to improve the understanding and management of NAFLD, potentially leading to better treatments in the future.

Gender

ALL

Eligibility 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