Skip to content
GeoClinicalTrials
Back to search

NCT04442334Recruiting

The European NAFLD Registry

Official recordSimplified version

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.

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.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
—
Study type
Observational
Countries
Switzerland, France, Germany, Italy, Belgium, Finland, Greece, Netherlands, Portugal, Spain, Sweden, United Kingdom
Sponsor
Newcastle University(Other)
Protocol no.
08759
Conditions
NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver, Steatosis of Liver, Hepatocellular Carcinoma, Cardiovascular Diseases, Type 2 Diabetes, Dyslipidaemia, Hypertension, Obesity, Other Associated Comorbidities
Interventions
—

Collaborators

Newcastle-upon-Tyne Hospitals NHS Trust, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Institute of Cardiometabolism and Nutrition, France, University of Cambridge, Örebro University, Sweden, University of Bern, University of Oxford, University of Turin, Italy, Angers University, University Hospital, Antwerp, Linkoeping University, University of Helsinki, UMC Utrecht, National and Kapodistrian University of Athens, University of Lisbon, University of Milan, University of Palermo, Catholic University of the Sacred Heart, Wuerzburg University Hospital, RWTH Aachen University, University of Nottingham, Medical University of Vienna, University of Birmingham, University of Florence, Assistance Publique - Hôpitaux de Paris, University Medical Center Mainz

Locations · 33

  • Bern, SwitzerlandInselspital, University HospitalRecruiting at this site
  • Angers, FranceLe Centre de Recherche Clinique (CRC) du CHU d'AngersRecruiting at this site
  • Paris, FranceInstitut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié SalpêtrièreRecruiting at this site
  • Mainz, GermanyUNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität MainzRecruiting at this site
  • Würzburg, GermanyUniversitätsklinikums WürzburgRecruiting at this site
  • Ancona, ItalyPolytechnic University of MarcheRecruiting at this site
  • Milan, ItalyUniversità degli Studi MilanoRecruiting at this site
  • Palermo, ItalyUniversità di PalermoRecruiting at this site
  • Rome, ItalyUniversità Cattolica del Sacro CuoreRecruiting at this site
  • Turin, ItalyDepartment of Medical Sciences University of TorinoRecruiting at this site
  • Antwerp, BelgiumUniversitair Ziekenhuis AntwerpenRecruiting at this site
  • Helsinki, FinlandHelsinki University HospitalRecruiting at this site
  • Athens, GreeceLaiko General Hospital of AthensRecruiting at this site
  • Amsterdam, NetherlandsAmsterdam UMCRecruiting at this site
  • Lisbon, PortugalHospital de Santa MariaRecruiting at this site
  • Barcelona, SpainVall d'Hebron University HospitalRecruiting at this site
  • Donostia / San Sebastian, SpainBiodonostia Health Research InstituteRecruiting at this site
  • Majadahonda, SpainPuerta de Hierro University HospitalRecruiting at this site
  • Santander, SpainMarqués de Valdecilla University HospitalRecruiting at this site
  • Seville, SpainInstitute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University HospitalRecruiting at this site
  • Valladolid, SpainHU Clínico de ValladolidRecruiting at this site
  • Huddinge, SwedenKarolinska UniversitetssjukhusetRecruiting at this site
  • Linköping, SwedenLinköping University HospitalRecruiting at this site
  • Birmingham, United KingdomUniversity Hospitals Birmingham Nhs Foundation TrustRecruiting at this site
  • Cambridge, United KingdomAddenbrooke'S HospitalRecruiting at this site
  • Hull, United KingdomHull Royal InfirmaryRecruiting at this site
  • London, United KingdomRoyal London Hospital, Barts Health NHS TrustRecruiting at this site
  • London, United KingdomSt George's University HospitalsRecruiting at this site
  • Newcastle upon Tyne, United KingdomThe Newcastle Upon Tyne Hospitals Nhs Foundation TrustRecruiting at this site
  • Nottingham, United KingdomQueen'S Medical CentreRecruiting at this site

In total, worldwide, 33 of the 37 sites listed in the registry are recruiting; the other 4 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: January 6, 2023).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

+ 3 more locations

Other identifiers

  • 634413 · other grant
  • 777377 · other grant

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.