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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Detailed Characterisation of the NAFLD Patient Phenotype — 1 day Prospective patient recruitment and collection of cross-sectional clinical data is undertaken (including clinical biochemistry/haematology, liver histology, comorbidities, prescribed medication and imaging data).These data will be used to determine number of participants exhibiting specific features of NAFLD/NASH disease severity at enrolment including: histological grade of disease and fibrosis stage (assessed using the well validated NASH Clinical Research Network "NAFLD Activity Score" \[NAS\] and the FLIP "Steatosis - Activity - Fibrosis" \[SAF\] systems), frequency of common metabolic comorbidities (eg type 2 diabetes mellitus, dyslipidaemia, cardiovascular disease), and associated changes in clinical biochemistry/haematology/imaging parameters. Biological samples to support clinical and translational research into disease pathophysiology (e.g. genetic, epigenetic, transcriptomic, metabolomic, proteomic and metagenomic datasets) and biomarker development/validation will be collected.
Trial sites (37)
Facility
City
Region
Status
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
UNIVERSITÄTSKLINIKUM der RWTH Aachen
Aachen
Germany
Not Yet Recruiting
Charité University Hospital Berlin
Berlin
Germany
Not Yet Recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau
Germany
Not Yet Recruiting
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz
Mainz
Germany
Recruiting
Universitätsklinikums Würzburg
Würzburg
Germany
Recruiting
Laiko General Hospital of Athens
Athens
Greece
Recruiting
Polytechnic University of Marche
Ancona
Italy
Recruiting
Università degli Studi Milano
Milan
Italy
Recruiting
Università di Palermo
Palermo
Italy
Recruiting
Università Cattolica del Sacro Cuore
Rome
Italy
Recruiting
Department of Medical Sciences University of Torino
Turin
Italy
Recruiting
Amsterdam UMC
Amsterdam
Netherlands
Recruiting
Hospital de Santa Maria
Lisbon
Portugal
Recruiting
Vall d'Hebron University Hospital
Barcelona
Spain
Recruiting
Biodonostia Health Research Institute
Donostia / San Sebastian
Spain
Recruiting
Puerta de Hierro University Hospital
Majadahonda
Spain
Recruiting
Marqués de Valdecilla University Hospital
Santander
Spain
Recruiting
Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital
Seville
Spain
Recruiting
HU Clínico de Valladolid
Valladolid
Spain
Recruiting
Karolinska Universitetssjukhuset
Huddinge
Sweden
Recruiting
Linköping University Hospital
Linköping
Sweden
Recruiting
Inselspital, University Hospital
Bern
Switzerland
Recruiting
University Hospitals Birmingham Nhs Foundation Trust
Birmingham
United Kingdom
Recruiting
Addenbrooke'S Hospital
Cambridge
United Kingdom
Recruiting
Queen Elizabeth Hospital
Gateshead
United Kingdom
Not Yet Recruiting
Hull Royal Infirmary
Hull
United Kingdom
Recruiting
Royal London Hospital, Barts Health NHS Trust
London
United Kingdom
Recruiting
St George's University Hospitals
London
United Kingdom
Recruiting
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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