Actively Recruiting

Age: 18Years - 100Years
All Genders
NCT04442334

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

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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