The European NAFLD Registry

Last updated: January 5, 2023
Sponsor: Newcastle University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stress

Liver Cancer

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT04442334
08759
777377
634413
  • Ages 18-100
  • All Genders

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years.

  2. Clinically suspected NAFLD based on any of:

  3. Patient with historical liver biopsy providing histological evidence of NAFLD or,

  4. Patient undergoing liver biopsy for suspected NAFLD with biochemical and/or radiological findings consistent with NAFLD or,

  5. 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).

  1. 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.

Study Design

Total Participants: 10000
Study Start date:
May 01, 2015
Estimated Completion Date:
December 31, 2030

Study Description

The European NAFLD Registry is a major international collaboration between clinical academics at leading universities across Europe, initially established with funding from the European Association for the Study of the Liver and through the EU FP7, H2020 and IMI2 schemes to the projects FLIP (Fatty Liver Inhibition of Progression), EPoS (Elucidating Pathways of Steatohepatitis) and LITMUS (Liver Investigation: Testing marker Utility in Steatohepatitis).

The Registry is a non-interventional, observational study collecting cross-sectional and longitudinal clinical data (including clinical biochemistry/haematology, liver histology, comorbidities, prescribed medication and imaging data) and linked biological samples (Blood [Serum, Plasma], Liver Tissue, Urine, Stool) from prospectively recruited patients with NAFLD. Its purpose is to support clinical and translational research into disease pathophysiology (through development of comprehensive genetic, epigenetic, transcriptomic, metabolomic, proteomic and metagenomic datasets) and biomarker development/validation. It supports collaborative discovery science and serves as the basis for a broad international project to discover and validate biomarkers for NAFLD and associated medical conditions (LITMUS). Out-with the current study, following separate ethical approval and after separate consent, patients who have agreed to join the European NAFLD Registry may also agree to participate in a number of nested sub-studies with bi-directional sharing of data. These include the LITMUS Imaging Study, which will acquire additional imaging data across a range of modalities including, amongst others, MR-PDFF and MR-Elastography. The Registry population comprises adult patients (aged ≥18 years) with risk factors for non-alcoholic fatty liver disease (NAFLD) prospectively recruited primarily in hepatology and diabetology clinics and/or bariatric surgery units at centres across Europe. After receiving informed consent, patients will be assigned a unique study identifier (which will be used to identify all data and samples collected) which will allow all information to be recorded in a link-anonymised form.

Connect with a study center

  • Universitair Ziekenhuis Antwerpen

    Antwerp,
    Belgium

    Active - Recruiting

  • Helsinki University Hospital

    Helsinki,
    Finland

    Active - Recruiting

  • Le Centre de Recherche Clinique (CRC) du CHU d'Angers

    Angers, 49933
    France

    Active - Recruiting

  • Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière

    Paris, 75013
    France

    Active - Recruiting

  • UNIVERSITÄTSKLINIKUM der RWTH Aachen

    Aachen, 52074
    Germany

    Site Not Available

  • Charité University Hospital Berlin

    Berlin,
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg, 79106
    Germany

    Site Not Available

  • UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz

    Mainz, 55131
    Germany

    Active - Recruiting

  • Universitätsklinikums Würzburg

    Würzburg, D-97080
    Germany

    Active - Recruiting

  • Laiko General Hospital of Athens

    Athens, 11527
    Greece

    Active - Recruiting

  • Polytechnic University of Marche

    Ancona,
    Italy

    Active - Recruiting

  • Università degli Studi Milano

    Milan,
    Italy

    Active - Recruiting

  • Università di Palermo

    Palermo,
    Italy

    Active - Recruiting

  • Università Cattolica del Sacro Cuore

    Rome,
    Italy

    Active - Recruiting

  • Department of Medical Sciences University of Torino

    Turin,
    Italy

    Active - Recruiting

  • Amsterdam UMC

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Hospital de Santa Maria

    Lisboa,
    Portugal

    Active - Recruiting

  • Vall d'Hebron University Hospital

    Barcelona,
    Spain

    Active - Recruiting

  • Biodonostia Health Research Institute

    Donostia,
    Spain

    Active - Recruiting

  • Puerta de Hierro University Hospital

    Majadahonda,
    Spain

    Active - Recruiting

  • Marqués de Valdecilla University Hospital

    Santander,
    Spain

    Active - Recruiting

  • Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital

    Sevilla,
    Spain

    Active - Recruiting

  • HU Clínico de Valladolid

    Valladolid,
    Spain

    Active - Recruiting

  • Karolinska Universitetssjukhuset

    Huddinge,
    Sweden

    Active - Recruiting

  • Linköping University Hospital

    Linköping,
    Sweden

    Active - Recruiting

  • Inselspital, University Hospital

    Bern,
    Switzerland

    Active - Recruiting

  • University Hospitals Birmingham Nhs Foundation Trust

    Birmingham,
    United Kingdom

    Active - Recruiting

  • Addenbrooke'S Hospital

    Cambridge,
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth Hospital

    Gateshead,
    United Kingdom

    Site Not Available

  • Hull Royal Infirmary

    Hull,
    United Kingdom

    Active - Recruiting

  • Royal London Hospital, Barts Health NHS Trust

    London,
    United Kingdom

    Active - Recruiting

  • St George's University Hospitals

    London,
    United Kingdom

    Active - Recruiting

  • The Newcastle Upon Tyne Hospitals Nhs Foundation Trust

    Newcastle-upon Tyne, NE7 7DN
    United Kingdom

    Active - Recruiting

  • Queen'S Medical Centre

    Nottingham,
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals Nhs Foundation Trust

    Oxford,
    United Kingdom

    Active - Recruiting

  • Derriford Hospital

    Plymouth,
    United Kingdom

    Active - Recruiting

  • Queen Alexandra Hospital

    Portsmouth,
    United Kingdom

    Active - Recruiting

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