The European NAFLD Registry

Recruiting now

Conditions studied: NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver, Steatosis of Liver, Hepatocellular Carcinoma, Cardiovascular Diseases, Type 2 Diabetes, Dyslipidaemia, Hypertension, Obesity, Other Associated Comorbidities

In brief

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.

Key facts

Study ID

NCT04442334

Run by

Newcastle University

People needed

10000

Starts

2015-05-01

Expected to finish

2030-12-31

Last updated by the study team

2023-01-06

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Queen Alexandra Hospital — Portsmouth, United Kingdom (enrolling)
• Helsinki University Hospital — Helsinki, Finland (enrolling)
• Le Centre de Recherche Clinique (CRC) du CHU d'Angers — Angers, France (enrolling)
• Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière — Paris, France (enrolling)
• Queen'S Medical Centre — Nottingham, United Kingdom (enrolling)
• Oxford University Hospitals Nhs Foundation Trust — Oxford, United Kingdom (enrolling)
• Derriford Hospital — Plymouth, United Kingdom (enrolling)
• Universitair Ziekenhuis Antwerpen — Antwerp, Belgium (enrolling)
• UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz — Mainz, Germany (enrolling)
• Universitätsklinikums Würzburg — Würzburg, Germany (enrolling)
• Laiko General Hospital of Athens — Athens, Greece (enrolling)
• Polytechnic University of Marche — Ancona, Italy (enrolling)
• Università degli Studi Milano — Milan, Italy (enrolling)
• Università di Palermo — Palermo, Italy (enrolling)
• Università Cattolica del Sacro Cuore — Rome, Italy (enrolling)
• Department of Medical Sciences University of Torino — Turin, Italy (enrolling)
• Amsterdam UMC — Amsterdam, Netherlands (enrolling)
• Hospital de Santa Maria — Lisbon, Portugal (enrolling)
• Vall d'Hebron University Hospital — Barcelona, Spain (enrolling)
• Biodonostia Health Research Institute — Donostia / San Sebastian, Spain (enrolling)
• Puerta de Hierro University Hospital — Majadahonda, Spain (enrolling)
• Marqués de Valdecilla University Hospital — Santander, Spain (enrolling)
• Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital — Seville, Spain (enrolling)
• HU Clínico de Valladolid — Valladolid, Spain (enrolling)
• Karolinska Universitetssjukhuset — Huddinge, Sweden (enrolling)

Full record on ClinicalTrials.gov

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