Clinical trial

The European NAFLD Registry

Recruiting now · Not applicable · 12 countries · Registry ID NCT04442334

Recruiting nowNot applicableObservational

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 100 Years
SexAll
Healthy volunteersNot accepted
ConditionNAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver, Steatosis of Liver, Hepatocellular Carcinoma, Cardiovascular Diseases, Type 2 Diabetes, Dyslipidaemia, Hypertension, Obesity, Other Associated Comorbidities

Full registry criteria

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.

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Detailed Characterisation of the NAFLD Patient Phenotype1 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,…

Study locations

37 locations were listed when this page was built. The first 40 are shown.

Universitair Ziekenhuis Antwerpen🇧🇪 Antwerp, Belgium
Sven M Francque, MD, PhDContact
Sven M Francque, MD, PhDPrincipal Investigator
Helsinki University Hospital🇫🇮 Helsinki, Finland
Hannele Yki-Järvinen, MDContact
Hannele Yki-Järvinen, MDPrincipal Investigator
Le Centre de Recherche Clinique (CRC) du CHU d'Angers🇫🇷 Angers, France
Jerome Boursier, MD, PhDContact
Jerome Boursier, MD, PhDPrincipal Investigator
Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière🇫🇷 Paris, France
Vlad Ratzu, MDContact
Vlad Ratzu, MDPrincipal Investigator
UNIVERSITÄTSKLINIKUM der RWTH Aachen🇩🇪 Aachen, Germany
Christian Trautwein, MDContact
Christian Trautwein, MDPrincipal Investigator
Charité University Hospital Berlin🇩🇪 Berlin, Germany
Muenevver Demir, MDContact
Muenevver Demir, MDPrincipal Investigator
Universitätsklinikum Freiburg🇩🇪 Freiburg im Breisgau, Germany
Rafael Kaeser, DrMedContact
Rafael Kaeser, DrMedPrincipal Investigator
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz🇩🇪 Mainz, Germany
Jörn M Schattenberg, DrMedContact
Jörn M Schattenberg, DrMedPrincipal Investigator
Universitätsklinikums Würzburg🇩🇪 Würzburg, Germany
Andreas Geier, MDContact
Andreas Geier, MDPrincipal Investigator
Laiko General Hospital of Athens🇬🇷 Athens, Greece
Gergios Papatheodoridis, MD, PhDContact
Gergios Papatheodoridis, MD, PhDPrincipal Investigator
Polytechnic University of Marche🇮🇹 Ancona, Italy
Gianluca Svegliati-Baroni, MDContact
Gianluca Svegliati-Baroni, MDPrincipal Investigator
Università degli Studi Milano🇮🇹 Milan, Italy
Luca Valenti, MDContact
Luca Valenti, MDPrincipal Investigator
Università di Palermo🇮🇹 Palermo, Italy
Salvatore Petta, MD, PhDContact
Salvatore Petta, MD, PhDPrincipal Investigator
Università Cattolica del Sacro Cuore🇮🇹 Rome, Italy
Luca Miele, MD, PhDContact
Luca Miele, MD, PhDPrincipal Investigator
Department of Medical Sciences University of Torino🇮🇹 Turin, Italy
Elisabetta Bugianesi, MD, PhDContact
Elisabetta Bugianesi, MD, PhDPrincipal Investigator
Amsterdam UMC🇳🇱 Amsterdam, Netherlands
A G Holleboom, MD, PhDContact
A G Holleboom, MD, PhDPrincipal Investigator
Ulrich Beuers, MD, PhDPrincipal Investigator
Hospital de Santa Maria🇵🇹 Lisbon, Portugal
Helena Cortez-Pinto, MD, PhDContact
Helena Cortez-Pinto, MD, PhDPrincipal Investigator
Vall d'Hebron University Hospital🇪🇸 Barcelona, Spain
Salva Augustin, MDContact
Salva Augustin, MDPrincipal Investigator
Biodonostia Health Research Institute🇪🇸 Donostia / San Sebastian, Spain
Jesus Banales, PhDContact
Jesus Banales, PhDPrincipal Investigator
Puerta de Hierro University Hospital🇪🇸 Majadahonda, Spain
Joseluis Calleja, MDContact
Joseluis Calleja, MDPrincipal Investigator
Marqués de Valdecilla University Hospital🇪🇸 Santander, Spain
Javier Crespo, MDContact
Javier Crespo, MDPrincipal Investigator
Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital🇪🇸 Seville, Spain
Manuel Romero-Gomez, MDContact
Manuel Romero-Gomez, MDPrincipal Investigator
HU Clínico de Valladolid🇪🇸 Valladolid, Spain
Rocío Aller de la Fuente, MD, PhDContact
Rocío Aller de la Fuente, MD, PhDPrincipal Investigator
Karolinska Universitetssjukhuset🇸🇪 Huddinge, Sweden
Hannes Hagstrom, MDContact
Hannes Hagstrom, MDPrincipal Investigator
Linköping University Hospital🇸🇪 Linköping, Sweden
Mattias Ekstedt, MDContact
Mattias Ekstedt, MDPrincipal Investigator
Inselspital, University Hospital🇨🇭 Bern, Switzerland
Jean-Francois Dufour, MD, PhDContact
Jean-Francois Dufour, MD, PhDPrincipal Investigator
University Hospitals Birmingham Nhs Foundation Trust🇬🇧 Birmingham, United Kingdom
Philip Newsome, MBChB, PhDContact
Philip Newsome, MBChB, PhDPrincipal Investigator
Addenbrooke'S Hospital🇬🇧 Cambridge, United Kingdom
Michael Allison, MBBS, PhDContact
Mike Allison, MBBS, PhDPrincipal Investigator
Queen Elizabeth Hospital🇬🇧 Gateshead, United Kingdom
Dina Mansour, MA, MBBSContact
Dina Mansour, MA, MBBSPrincipal Investigator
Hull Royal Infirmary🇬🇧 Hull, United Kingdom
Lynsey Corless, MBChB, PhDContact
Lynsey Corless, MBChB, PhDPrincipal Investigator
Royal London Hospital, Barts Health NHS Trust🇬🇧 London, United Kingdom
William Alazawi, MBBC, PhDContact
William Alazawi, MBBC, PhDPrincipal Investigator
St George's University Hospitals🇬🇧 London, United Kingdom
Metin Devrim, MSc, MBBSContact
Metin Devrim, MSc, MBBSPrincipal Investigator
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust🇬🇧 Newcastle upon Tyne, United Kingdom
Quentin M Anstee, MBBS, PhDContact
Quentin M Anstee, MBBS, PhDPrincipal Investigator
Queen'S Medical Centre🇬🇧 Nottingham, United Kingdom
Guru Aithal, MD, PhDContact
Guru Aithal, MD, PhDPrincipal Investigator
Oxford University Hospitals Nhs Foundation Trust🇬🇧 Oxford, United Kingdom
Jeremy Cobbold, MBBS MA PhDContact
Jeremy Cobbold, MBBS MA PhDPrincipal Investigator
Derriford Hospital🇬🇧 Plymouth, United Kingdom
David Sheridan, MBBS, PhDContact
David Sheridan, MBBS, PhDPrincipal Investigator
Queen Alexandra Hospital🇬🇧 Portsmouth, United Kingdom
Joanna Dowman, MBChB, PhDContact
Joanna Dowman, MBChB, PhDPrincipal Investigator