The search for biomarkers to enable detection and monitoring of disease progression from NAFLD to NASH and NASH itself; Amsterdam NASH cohort

Recruiting

Conditions: non-alcoholic fatty liver disease
steatohepatitis
10018424
10019654

Registration Number: NL-OMON52739

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

• Diagnosis of steatosis hepatis on ultrasound or by biopsy or on Fibroscan
with CAP >280dB/m
• >18 years of age
• ASAT and/or ALAT levels above upper limit of normal in six months prior to
inclusion
• BMI >25 kg/m2

Exclusion Criteria

• Abusive alcohol use (>20 IU/week)
• Hepatitis B and/or C
• Auto-immune hepatitis
• Wilsons disease/ alpha-1-antitripsine deficiency
• Haemachromatose
• Bleeding disorder, including the use of anticoagulant therapy and platelet
aggregation inhibitors. Except for subjects using platelet aggregation
inhibition monotherapy for the prevention of cardiovascular disease and without
a history of any coronary events. In this case the platelet aggregation
inhibitor will be discontinued for 7 days before the liver biopsy is performed.
• Use of drugs with a potential role in aggravation of pre-existing NAFLD
• Not able or willing to undergo MRI (for example claustrophobia, ICD,
pacemaker).
• Diagnosis of liver cirrhosis and/or hepatocellular carcinoma.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>primary outcome is identification of new riskfactors in patients with steatosis<br /><br>hepatis on abdominal ultrasound that develop NASH from NAFLD This includes<br /><br>study of specific hepatic gene expression (RNAseq), plasma markers<br /><br>(metabolites), DNA methylation and intestinaal microbiota composition to<br /><br>identify rapid and slow NAFLD-NASH progressors. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>to apply a systems biology approach to identify the hierarchy of driving<br /><br>mechanisms (microbial and metabolic markers) involved in the conversion of<br /><br>NAFLD-NASH and NASH-Cirrhosis after 5 years that can be used for the<br /><br>development of novel treatment options in NASH<br /><br>1. dietary and satiety lists and excreted metabolites (24h faeces and urine as<br /><br>well as BIA and questionnaires)<br /><br>2. Faecal and oral microbiota composition in relation to plasma metabolites in<br /><br>NAFLD-NASH progression as well as NASH-Cirrhosis progression </p><br>