A registry for studying Non-Alcoholic Fatty Liver Disease in Europe

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The European NAFLD Registry is an observational study that collects clinical data and biological samples from patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH). It aims to understand the disease's natural history, clinical phenotype, and outcomes, while also developing and validating biomarkers for disease progression. The study involves collaboration among leading universities and medical centers across Europe, utilizing comprehensive datasets to support translational research into the pathophysiology of NAFLD. Patients may also participate in nested sub-studies with additional consent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years.
2. Clinically suspected NAFLD based on any of:

   1. Patient with historical liver biopsy providing histological evidence of NAFLD or,
   2. Patient undergoing liver biopsy for suspected NAFLD with biochemical and/or radiological findings consistent with NAFLD or,
   3. Patient with radiological evidence of cirrhosis (in absence of an alternative aetiology) plus presence of ≥2 features indicative of the 'metabolic syndrome':

      * Increased waist circumference by ethnically adjusted criteria (e.g. Europid male/female ≥94cm/80cm) or overweight/obese (BMI ≥25);
      * Raised fasting glucose ≥100 mg/dL \[5.6 mmol/L\], HbA1c ≥48mmol/mol (6.5%) or previously diagnosed insulin resistance/type 2 diabetes mellitus (or on treatment);
      * Dyslipidaemia (fasting TG level ≥150 mg/dL \[1.7 mmol/L\]; or fasting HDL \<40 mg/dL \[1.03 mmol/L\] in males and \<50 mg/dL \[1.29 mmol/L\] in females; or on treatment);
      * Hypertension (systolic BP ≥130 or diastolic BP ≥85 mmHg, or on treatment).
3. Average alcohol consumption less than 21/14 units/week (males/females) in preceding 6 months and no history of sustained excessive consumption of alcohol in past 5 years.

Exclusion Criteria

1. Refusal or inability (lack of capacity) to give informed consent.
2. Average alcohol ingestion greater than approximately 21/14 units/week (males/females) in preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years.
3. History or presence of Type 1 diabetes mellitus.
4. Presence of any other form of chronic liver disease except NAFLD.
5. Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \[\>10 days\], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid).
6. Any contra-indication to liver biopsy.
7. Recent (within 3 months) change in dose/regimen or introduction of Vitamin E (at a dose ≥400 IU/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline.
8. Non-English speaking/unable to access an interpreter. Due to the nature of the study, English language or access to a relevant interpreter is a necessary criterion to ensure lifestyle (diet and exercise) and symptom data are collated.
9. Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.

Where it's running

• Universitair Ziekenhuis Antwerpen
  Antwerp, Belgium Recruiting
• Helsinki University Hospital
  Helsinki, Finland Recruiting
• Le Centre de Recherche Clinique (CRC) du CHU d'Angers
  Angers, France Recruiting
• Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière
  Paris, France Recruiting
• UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz
  Mainz, Germany Recruiting
• Universitätsklinikums Würzburg
  Würzburg, Germany Recruiting

Study contacts

• Principal investigator: Quentin M Anstee, MBBS, PhD — Newcastle University
• Study coordinator: Quentin M Anstee, MBBS, PhD
• Email: quentin.anstee@ncl.ac.uk
• Phone: +44(0)191 20 87012

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.