on-invasive diagnosis of non-alcoholic steatohepatitis in patients with non-alcoholic fatty liver disease using markers and imaging techniques

Recruiting

Conditions: fatty liver with inflammation
non-alcoholic steatohepatitis
10019654

Registration Number: NL-OMON47211

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 110

Inclusion Criteria

- NAFLD proven by imaging
- Age 18-65 years

Exclusion Criteria

- 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.
- 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
- Unwilling to collect biosamples.
- Pregnancy and breastfeeding.
- Diagnosis of liver cirrhosis and/or hepatocellular carcinoma.
- Current diagnosis of extrahepatic malignancie(s) or prior diagnosis within last 5 years.
- Diagnosis of chronic inflammatory disease (i.e. inflammatory bowel disease, rheumatoid arthritis, inflammatory lung disease, severe infectious diseases), other than NAFLD/NASH
- Chronic use of immunosuppressants (e.g. biologicals, prednisolone, azathioprine)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of this cohort is to identify non-invasive tools,<br /><br>consisting of biomarkers and imaging, to diagnose NASH. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The investigated paramters will be investigated to identify an association<br /><br>between the parameters and disease severity (e.g. steatosis grade, fibrosis<br /><br>grade).<br /><br>- The effect of a pre-operative low calorie diet on hepatic steaosis and<br /><br>inflammation will be investigated with a fibroscan (+CAP) and different<br /><br>non-invasive markers for hepatic inflammation. </p><br>