The European NAFLD Registry
Recruiting · NCT04442334 · Observational (researchers observe without assigning treatment) · Lead sponsor: Newcastle University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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 it is running
37 locations listed.
- UNIVERSITÄTSKLINIKUM der RWTH Aachen - Aachen, Germany
- Amsterdam UMC - Amsterdam, Netherlands
- Polytechnic University of Marche - Ancona, Italy
- Le Centre de Recherche Clinique (CRC) du CHU d'Angers - Angers, France
- Universitair Ziekenhuis Antwerpen - Antwerp, Belgium
- Laiko General Hospital of Athens - Athens, Greece
- Vall d'Hebron University Hospital - Barcelona, Spain
- Charité University Hospital Berlin - Berlin, Germany
- Inselspital, University Hospital - Bern, Switzerland
- University Hospitals Birmingham Nhs Foundation Trust - Birmingham, United Kingdom
- Addenbrooke'S Hospital - Cambridge, United Kingdom
- Biodonostia Health Research Institute - Donostia / San Sebastian, Spain
- Universitätsklinikum Freiburg - Freiburg im Breisgau, Germany
- Queen Elizabeth Hospital - Gateshead, United Kingdom
- Helsinki University Hospital - Helsinki, Finland
- Karolinska Universitetssjukhuset - Huddinge, Sweden
- Hull Royal Infirmary - Hull, United Kingdom
- Linköping University Hospital - Linköping, Sweden
- Hospital de Santa Maria - Lisbon, Portugal
- Royal London Hospital, Barts Health NHS Trust - London, United Kingdom
- St George's University Hospitals - London, United Kingdom
- UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz - Mainz, Germany
- Puerta de Hierro University Hospital - Majadahonda, Spain
- Università degli Studi Milano - Milan, Italy
- The Newcastle Upon Tyne Hospitals Nhs Foundation Trust - Newcastle upon Tyne, United Kingdom
- Queen'S Medical Centre - Nottingham, United Kingdom
- Oxford University Hospitals Nhs Foundation Trust - Oxford, United Kingdom
- Università di Palermo - Palermo, Italy
- Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière - Paris, France
- Derriford Hospital - Plymouth, United Kingdom
- Queen Alexandra Hospital - Portsmouth, United Kingdom
- Università Cattolica del Sacro Cuore - Rome, Italy
- Marqués de Valdecilla University Hospital - Santander, Spain
- Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital - Seville, Spain
- Department of Medical Sciences University of Torino - Turin, Italy
- HU Clínico de Valladolid - Valladolid, Spain
- Universitätsklinikums Würzburg - Würzburg, Germany