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Clinical Trials in Germany / NCT04442334
Recruiting Observational

The European NAFLD Registry

NCT04442334 · tracked via the Priya Life Science Germany tracker
Sponsor
Newcastle University
Phase
Observational
Started
2015-05-01
Last updated
2023-01-06

Condition(s) studied

NAFLDNASHNASH - Nonalcoholic SteatohepatitisFibrosis, LiverSteatosis of LiverHepatocellular CarcinomaCardiovascular DiseasesType 2 DiabetesDyslipidaemiaHypertensionObesityOther Associated Comorbidities

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

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
Universitair Ziekenhuis Antwerpen Antwerp Belgium Recruiting
Helsinki University Hospital Helsinki Finland Recruiting
Le Centre de Recherche Clinique (CRC) du CHU d'Angers Angers France Recruiting
Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière Paris France Recruiting
UNIVERSITÄTSKLINIKUM der RWTH Aachen Aachen Germany Not Yet Recruiting
Charité University Hospital Berlin Berlin Germany Not Yet Recruiting
Universitätsklinikum Freiburg Freiburg im Breisgau Germany Not Yet Recruiting
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz Mainz Germany Recruiting
Universitätsklinikums Würzburg Würzburg Germany Recruiting
Laiko General Hospital of Athens Athens Greece Recruiting
Polytechnic University of Marche Ancona Italy Recruiting
Università degli Studi Milano Milan Italy Recruiting
Università di Palermo Palermo Italy Recruiting
Università Cattolica del Sacro Cuore Rome Italy Recruiting
Department of Medical Sciences University of Torino Turin Italy Recruiting
Amsterdam UMC Amsterdam Netherlands Recruiting
Hospital de Santa Maria Lisbon Portugal Recruiting
Vall d'Hebron University Hospital Barcelona Spain Recruiting
Biodonostia Health Research Institute Donostia / San Sebastian Spain Recruiting
Puerta de Hierro University Hospital Majadahonda Spain Recruiting
Marqués de Valdecilla University Hospital Santander Spain Recruiting
Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital Seville Spain Recruiting
HU Clínico de Valladolid Valladolid Spain Recruiting
Karolinska Universitetssjukhuset Huddinge Sweden Recruiting
Linköping University Hospital Linköping Sweden Recruiting
Inselspital, University Hospital Bern Switzerland Recruiting
University Hospitals Birmingham Nhs Foundation Trust Birmingham United Kingdom Recruiting
Addenbrooke'S Hospital Cambridge United Kingdom Recruiting
Queen Elizabeth Hospital Gateshead United Kingdom Not Yet Recruiting
Hull Royal Infirmary Hull United Kingdom Recruiting
Royal London Hospital, Barts Health NHS Trust London United Kingdom Recruiting
St George's University Hospitals London United Kingdom Recruiting
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust Newcastle upon Tyne United Kingdom Recruiting
Queen'S Medical Centre Nottingham United Kingdom Recruiting
Oxford University Hospitals Nhs Foundation Trust Oxford United Kingdom Recruiting
Derriford Hospital Plymouth United Kingdom Recruiting
Queen Alexandra Hospital Portsmouth United Kingdom Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04442334 on ClinicalTrials.gov ↗ ← All trials in Germany