Actively Recruiting
The European NAFLD Registry
Led by Newcastle University · Updated on 2023-01-06
10000
Participants Needed
37
Research Sites
817 weeks
Total Duration
On this page
Sponsors
N
Newcastle University
Lead Sponsor
N
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The European NAFLD Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinically suspected NAFLD based on any of the following: historical liver biopsy showing NAFLD, liver biopsy for suspected NAFLD with supportive biochemical or radiological findings, or radiological evidence of cirrhosis plus at least two metabolic syndrome features (increased waist circumference or overweight/obesity, raised fasting glucose or diagnosed insulin resistance/type 2 diabetes, dyslipidaemia, hypertension)
- Average alcohol consumption less than 21 units/week for males or less than 14 units/week for females in the past 6 months with no history of sustained excessive alcohol use in the past 5 years
You will not qualify if you...
- Refusal or inability to give informed consent
- Average alcohol intake greater than approximately 21 units/week for males or 14 units/week for females in the past 6 months or history of sustained excessive alcohol use in past 5 years
- Diagnosis or history of type 1 diabetes mellitus
- Presence of any chronic liver disease other than NAFLD
- Recent (within 12 months) or current use of drugs known to cause fatty liver such as long-term corticosteroids, amiodarone, methotrexate, tamoxifen, tetracycline, high dose estrogens, or valproic acid
- Contraindications to liver biopsy
- Recent (within 3 months) changes in dose or start of Vitamin E (>400 IU/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin, or pentoxifylline
- Inability to speak English or lack of access to an interpreter
- Patients not meeting inclusion criteria or judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 37 locations
1
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
Actively Recruiting
2
Helsinki University Hospital
Helsinki, Finland
Actively Recruiting
3
Le Centre de Recherche Clinique (CRC) du CHU d'Angers
Angers, France, 49933
Actively Recruiting
4
Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
5
UNIVERSITÄTSKLINIKUM der RWTH Aachen
Aachen, Germany, 52074
Not Yet Recruiting
6
Charité University Hospital Berlin
Berlin, Germany
Not Yet Recruiting
7
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Not Yet Recruiting
8
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz
Mainz, Germany, 55131
Actively Recruiting
9
Universitätsklinikums Würzburg
Würzburg, Germany, D-97080
Actively Recruiting
10
Laiko General Hospital of Athens
Athens, Greece, 11527
Actively Recruiting
11
Polytechnic University of Marche
Ancona, Italy
Actively Recruiting
12
Università degli Studi Milano
Milan, Italy
Actively Recruiting
13
Università di Palermo
Palermo, Italy
Actively Recruiting
14
Università Cattolica del Sacro Cuore
Rome, Italy
Actively Recruiting
15
Department of Medical Sciences University of Torino
Turin, Italy
Actively Recruiting
16
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
17
Hospital de Santa Maria
Lisbon, Portugal
Actively Recruiting
18
Vall d'Hebron University Hospital
Barcelona, Spain
Actively Recruiting
19
Biodonostia Health Research Institute
Donostia / San Sebastian, Spain
Actively Recruiting
20
Puerta de Hierro University Hospital
Majadahonda, Spain
Actively Recruiting
21
Marqués de Valdecilla University Hospital
Santander, Spain
Actively Recruiting
22
Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital
Seville, Spain
Actively Recruiting
23
HU Clínico de Valladolid
Valladolid, Spain
Actively Recruiting
24
Karolinska Universitetssjukhuset
Huddinge, Sweden
Actively Recruiting
25
Linköping University Hospital
Linköping, Sweden
Actively Recruiting
26
Inselspital, University Hospital
Bern, Switzerland
Actively Recruiting
27
University Hospitals Birmingham Nhs Foundation Trust
Birmingham, United Kingdom
Actively Recruiting
28
Addenbrooke'S Hospital
Cambridge, United Kingdom
Actively Recruiting
29
Queen Elizabeth Hospital
Gateshead, United Kingdom
Not Yet Recruiting
30
Hull Royal Infirmary
Hull, United Kingdom
Actively Recruiting
31
Royal London Hospital, Barts Health NHS Trust
London, United Kingdom
Actively Recruiting
32
St George's University Hospitals
London, United Kingdom
Actively Recruiting
33
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
34
Queen'S Medical Centre
Nottingham, United Kingdom
Actively Recruiting
35
Oxford University Hospitals Nhs Foundation Trust
Oxford, United Kingdom
Actively Recruiting
36
Derriford Hospital
Plymouth, United Kingdom
Actively Recruiting
37
Queen Alexandra Hospital
Portsmouth, United Kingdom
Actively Recruiting
Research Team
Q
Quentin M Anstee, MBBS, PhD
CONTACT
K
Kristy L Wonders, BA, MLitt
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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