Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10000 participants
OBSERVATIONAL
2015-05-01
2030-12-31
Brief Summary
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Detailed Description
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The Registry is a non-interventional, observational study collecting cross-sectional and longitudinal clinical data (including clinical biochemistry/haematology, liver histology, comorbidities, prescribed medication and imaging data) and linked biological samples (Blood \[Serum, Plasma\], Liver Tissue, Urine, Stool) from prospectively recruited patients with NAFLD. Its purpose is to support clinical and translational research into disease pathophysiology (through development of comprehensive genetic, epigenetic, transcriptomic, metabolomic, proteomic and metagenomic datasets) and biomarker development/validation. It supports collaborative discovery science and serves as the basis for a broad international project to discover and validate biomarkers for NAFLD and associated medical conditions (LITMUS). Out-with the current study, following separate ethical approval and after separate consent, patients who have agreed to join the European NAFLD Registry may also agree to participate in a number of nested sub-studies with bi-directional sharing of data. These include the LITMUS Imaging Study, which will acquire additional imaging data across a range of modalities including, amongst others, MR-PDFF and MR-Elastography. The Registry population comprises adult patients (aged ≥18 years) with risk factors for non-alcoholic fatty liver disease (NAFLD) prospectively recruited primarily in hepatology and diabetology clinics and/or bariatric surgery units at centres across Europe. After receiving informed consent, patients will be assigned a unique study identifier (which will be used to identify all data and samples collected) which will allow all information to be recorded in a link-anonymised form.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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The LITMUS Study Cohort
Prospectively recruited NAFLD patients, recruited according to The European NAFLD Registry study protocol.
No interventions assigned to this group
The LITMUS Metacohort
Collated data and biological samples on patients with histologically characterised NAFLD prospectively recruited at contributing academic centres across Europe.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
100 Years
ALL
No
Sponsors
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Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Institute of Cardiometabolism and Nutrition, France
OTHER
University of Cambridge
OTHER
Örebro University, Sweden
OTHER
University of Bern
OTHER
University of Oxford
OTHER
University of Turin, Italy
OTHER
University of Angers
UNKNOWN
University Hospital, Antwerp
OTHER
Linkoeping University
OTHER_GOV
University of Helsinki
OTHER
UMC Utrecht
OTHER
National and Kapodistrian University of Athens
OTHER
University of Lisbon
OTHER
University of Milan
OTHER
University of Palermo
OTHER
Catholic University of the Sacred Heart
OTHER
Wuerzburg University Hospital
OTHER
RWTH Aachen University
OTHER
University of Nottingham
OTHER
Medical University of Vienna
OTHER
University of Birmingham
OTHER
University of Florence
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
University Medical Center Mainz
OTHER
Newcastle University
OTHER
Responsible Party
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Principal Investigators
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Quentin M Anstee, MBBS, PhD
Role: PRINCIPAL_INVESTIGATOR
Newcastle University
Locations
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Universitair Ziekenhuis Antwerpen
Antwerp, , Belgium
Helsinki University Hospital
Helsinki, , Finland
Le Centre de Recherche Clinique (CRC) du CHU d'Angers
Angers, , France
Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière
Paris, , France
UNIVERSITÄTSKLINIKUM der RWTH Aachen
Aachen, , Germany
Charité University Hospital Berlin
Berlin, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz
Mainz, , Germany
Universitätsklinikums Würzburg
Würzburg, , Germany
Laiko General Hospital of Athens
Athens, , Greece
Polytechnic University of Marche
Ancona, , Italy
Università degli Studi Milano
Milan, , Italy
Università di Palermo
Palermo, , Italy
Università Cattolica del Sacro Cuore
Rome, , Italy
Department of Medical Sciences University of Torino
Turin, , Italy
Amsterdam UMC
Amsterdam, , Netherlands
Hospital de Santa Maria
Lisbon, , Portugal
Vall d'Hebron University Hospital
Barcelona, , Spain
Biodonostia Health Research Institute
Donostia / San Sebastian, , Spain
Puerta de Hierro University Hospital
Majadahonda, , Spain
Marqués de Valdecilla University Hospital
Santander, , Spain
Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital
Seville, , Spain
HU Clínico de Valladolid
Valladolid, , Spain
Karolinska Universitetssjukhuset
Huddinge, , Sweden
Linköping University Hospital
Linköping, , Sweden
Inselspital, University Hospital
Bern, , Switzerland
University Hospitals Birmingham Nhs Foundation Trust
Birmingham, , United Kingdom
Addenbrooke'S Hospital
Cambridge, , United Kingdom
Queen Elizabeth Hospital
Gateshead, , United Kingdom
Hull Royal Infirmary
Hull, , United Kingdom
Royal London Hospital, Barts Health NHS Trust
London, , United Kingdom
St George's University Hospitals
London, , United Kingdom
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
Newcastle upon Tyne, , United Kingdom
Queen'S Medical Centre
Nottingham, , United Kingdom
Oxford University Hospitals Nhs Foundation Trust
Oxford, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Queen Alexandra Hospital
Portsmouth, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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McGlinchey AJ, Govaere O, Geng D, Ratziu V, Allison M, Bousier J, Petta S, de Oliviera C, Bugianesi E, Schattenberg JM, Daly AK, Hyotylainen T, Anstee QM, Oresic M. Metabolic signatures across the full spectrum of non-alcoholic fatty liver disease. JHEP Rep. 2022 Mar 26;4(5):100477. doi: 10.1016/j.jhepr.2022.100477. eCollection 2022 May.
Other Identifiers
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634413
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
777377
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
08759
Identifier Type: -
Identifier Source: org_study_id
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