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.
Age ≥18 years.
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,
Increased waist circumference by ethnically adjusted criteria (e.g. Europid male/female ≥94cm/80cm) or overweight/obese (BMI ≥25);
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.
Adult patients with a pre-existing liver biopsy providing histological evidence of NAFLD or, patients undergoing liver biopsy for suspected NAFLD with biochemical and/or radiological findings consistent with NAFLD, or patients with radiological evidence of cirrhosis (in absence of an alternative aetiology) plus presence of ≥2 features indicative of the 'metabolic syndrome'.
Cohort
Prospective
Not listed
Detailed Characterisation of the NAFLD Patient Phenotype
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.
Disease Natural History
Longitudinal follow-up of patients with NAFLD by annual review to characterise disease natural history and determine number of participants experiencing clinically significant events including the occurrence and timing of incident comorbidities and key target conditions of interest such as: * Death (cause of death) * Major Adverse Cardiovascular Events (MACE) * Hepatic (e.g. diagnosis of cirrhosis, hepatic decompensation, hepatocellular carcinoma, transplantation) * Other (diagnosis of extra-hepatic malignancy/emergency hospitalisation) Routine clinical data generated as part of standard care will be collected annually. Clinical parameters assessed for changes indicative of alteration in disease state during follow-up include: clinical biochemistry/haematology, liver histology, comorbidities, prescribed medication and imaging data. Biological samples to support translational research into disease pathophysiology and biomarker development/validation will also be collected.
Lifestyle factors: Dietary Habits
Cross-sectional and longitudinal study of dietary habits in patients with NAFLD using: Mediterranean Diet Score.
Lifestyle factors: Activity/Exercise
Cross-sectional and longitudinal study of lifestyle factors (e.g. activity/sedentary behaviour/exercise levels) in patients with NAFLD using: International Physical Activity Questionnaire (IPAQ).
Health Related Quality of Life: CLDQ
Cross-sectional and longitudinal collection of standardised data on HRQOL and symptom burden in patients with NAFLD using Patient Reported Outcome Measure (PROM): Chronic Liver Disease Questionnaire for NAFLD NASH (CLDQ NAFLD-NASH).
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Newcastle University
Lead sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator
Institute of Cardiometabolism and Nutrition, France
Collaborator
University of Cambridge
Collaborator
Örebro University, Sweden
Collaborator
University of Bern
Collaborator
University of Oxford
Collaborator
University of Turin, Italy
Collaborator
Angers University
Collaborator
University Hospital, Antwerp
Collaborator
Linkoeping University
Collaborator
University of Helsinki
Collaborator
UMC Utrecht
Collaborator
National and Kapodistrian University of Athens
Collaborator
University of Lisbon
Collaborator
University of Milan
Collaborator
University of Palermo
Collaborator
Catholic University of the Sacred Heart
Collaborator
Wuerzburg University Hospital
Collaborator
RWTH Aachen University
Collaborator
University of Nottingham
Collaborator
Medical University of Vienna
Collaborator
University of Birmingham
Collaborator
University of Florence
Collaborator
Assistance Publique - Hôpitaux de Paris
Collaborator
University Medical Center Mainz
Collaborator
