Disease mechanisms and markers for non-alcoholic steatohepatitis in a population with non-alcoholic fatty liver disaese: a prospective cohort study with biobank

Completed

• Conditions: fatty liver; Non-alcoholic fatty liver disease; 10017943; 10019654

• Registration Number: NL-OMON47388
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

- NAFLD diagnosis based on evidence of hepatic steatosis, either by imaging (any form) or by histology
- BMI >= 25
- 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 (excluding hemochromatosis)
- Ethanol consumption exceeding more than 14 standard beverages per week for males and more than 7 standard beverages per week for female.
- Unwilling to collect biosamples
- Pregnancy and breastfeeding.
- A history of bariatric surgery.
- Diagnosis of liver cirrhosis and/or hepatocellular carcinoma.
- Diagnosis of extrahepatic malignancies
- 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 (e.g., after 3 months are myocardial infarction patients are eligible for participation).

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of this cohort is the diagnosis NASH</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Furthermore different parameters ([epi-]genetic, lifestyle, metabolic,<br /><br>inflammatory and microbial parameters) associated with NASH in a cohort NAFLD<br /><br>patients will be investigated cross-sectionally and longitudinally. The degree<br /><br>of hepatic steatosis and/or fibrosis (e.g. using MRI and Fibroscan) and the<br /><br>presence of hepatic inflammation (e.g. using biochemical parameters and MRI)<br /><br>will be assessed. Additionally, the prevalence of (extra)hepatic complications<br /><br>of NAFLD will be evaluated.</p><br>