The European NAFLD Registry

Status: Recruiting
Location: See all (37) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
Universitair Ziekenhuis Antwerpen
RECRUITING
Antwerp
Finland
Helsinki University Hospital
RECRUITING
Helsinki
France
Le Centre de Recherche Clinique (CRC) du CHU d'Angers
RECRUITING
Angers
Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière
RECRUITING
Paris
Germany
UNIVERSITÄTSKLINIKUM der RWTH Aachen
NOT_YET_RECRUITING
Aachen
Charité University Hospital Berlin
NOT_YET_RECRUITING
Berlin
Universitätsklinikum Freiburg
NOT_YET_RECRUITING
Freiburg Im Breisgau
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz
RECRUITING
Mainz
Universitätsklinikums Würzburg
RECRUITING
Würzburg
Greece
Laiko General Hospital of Athens
RECRUITING
Athens
Italy
Polytechnic University of Marche
RECRUITING
Ancona
Università degli Studi Milano
RECRUITING
Milan
Università di Palermo
RECRUITING
Palermo
Università Cattolica del Sacro Cuore
RECRUITING
Rome
Department of Medical Sciences University of Torino
RECRUITING
Turin
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Portugal
Hospital de Santa Maria
RECRUITING
Lisbon
Spain
Vall d'Hebron University Hospital
RECRUITING
Barcelona
Biodonostia Health Research Institute
RECRUITING
Donostia / San Sebastian
Puerta de Hierro University Hospital
RECRUITING
Majadahonda
Marqués de Valdecilla University Hospital
RECRUITING
Santander
Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital
RECRUITING
Seville
HU Clínico de Valladolid
RECRUITING
Valladolid
Sweden
Karolinska Universitetssjukhuset
RECRUITING
Huddinge
Linköping University Hospital
RECRUITING
Linköping
Switzerland
Inselspital, University Hospital
RECRUITING
Bern
United Kingdom
University Hospitals Birmingham Nhs Foundation Trust
RECRUITING
Birmingham
Addenbrooke'S Hospital
RECRUITING
Cambridge
Queen Elizabeth Hospital
NOT_YET_RECRUITING
Gateshead
Hull Royal Infirmary
RECRUITING
Hull
Royal London Hospital, Barts Health NHS Trust
RECRUITING
London
St George's University Hospitals
RECRUITING
London
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
RECRUITING
Newcastle Upon Tyne
Queen'S Medical Centre
RECRUITING
Nottingham
Oxford University Hospitals Nhs Foundation Trust
RECRUITING
Oxford
Derriford Hospital
RECRUITING
Plymouth
Queen Alexandra Hospital
RECRUITING
Portsmouth
Contact Information
Primary
Quentin M Anstee, MBBS, PhD
quentin.anstee@ncl.ac.uk
+44(0)191 20 87012
Backup
Kristy L Wonders, BA, MLitt
kristy.wonders@ncl.ac.uk
+44(0)191 2083959
Time Frame
Start Date: 2015-05-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 10000
Treatments
The LITMUS Study Cohort
Prospectively recruited NAFLD patients, recruited according to The European NAFLD Registry study protocol.
The LITMUS Metacohort
Collated data and biological samples on patients with histologically characterised NAFLD prospectively recruited at contributing academic centres across Europe.
EFPIA Clinical Trial Cohort
Collated data and biological samples on patients with histologically characterised NAFLD that have participated in phase 2 and phase 3 trials of IMPs for NAFLD.
Sponsors
Collaborators: University of Palermo, Catholic University of the Sacred Heart, University of Cambridge, Newcastle-upon-Tyne Hospitals NHS Trust, University of Turin, Italy, University of Angers, National and Kapodistrian University of Athens, University of Helsinki, University of Birmingham, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Oxford, Wuerzburg University Hospital, University of Milan, UMC Utrecht, Linkoeping University, RWTH Aachen University, Medical University of Vienna, University of Nottingham, Institute of Cardiometabolism and Nutrition, France, Assistance Publique - Hôpitaux de Paris, University of Lisbon, University Hospital, Antwerp, Örebro University, Sweden, University of Bern, University of Florence, University Medical Center Mainz
Leads: Newcastle University

This content was sourced from clinicaltrials.gov