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The European NAFLD Registry

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About this study

The European NAFLD Registry is a prospectively recruited, observational study supporting the study of the clinical phenotype, natural history, disease outcomes and pathophysiology of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis. The ultimate goals are to better understand the drivers of interpatient variation in disease pathophysiology and severity and to utilise this information to develop and validate biomarkers that, singly or in combination, enable detection and monitoring of disease progression and/or from NAFL through NASH to fibrosis and cirrhosis.

Condition
NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver, Steatosis of Liver, Hepatocellular Carcinoma, Cardiovascular Diseases, Type 2 Diabetes, Dyslipidaemia, Hypertension, Obesity, Other Associated Comorbidities
Sponsor
Newcastle University

Who can join

Age
18 to 100 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 13

  • Minimum age: 18 years
  • Maximum age: 100 years
  • Study condition: NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver, Steatosis of Liver, Hepatocellular Carcinoma, Cardiovascular Diseases, Type 2 Diabetes, Dyslipidaemia, Hypertension, Obesity, Other Associated Comorbidities
  • Age ≥18 years.
  • Clinically suspected NAFLD based on any of:
  • Patient with historical liver biopsy providing histological evidence of NAFLD or,
  • Patient undergoing liver biopsy for suspected NAFLD with biochemical and/or radiological findings consistent with NAFLD or,
  • 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).
  • 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 9

  • Refusal or inability (lack of capacity) to give informed consent.
  • 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.
  • History or presence of Type 1 diabetes mellitus.
  • Presence of any other form of chronic liver disease except NAFLD.
  • 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).
  • Any contra-indication to liver biopsy.
  • 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.
  • 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.
  • Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.

Where

37 sites, 37 recruiting

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

and 31 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.