At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 187 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
In plain English
This is a registry collecting information from adults with non-alcoholic fatty liver disease (NAFLD), a condition where fat builds up in the liver. It is run by Newcastle University. The registry gathers health and lifestyle information from people with NAFLD and related conditions such as diabetes, heart disease and obesity.
Who can take part
- Adults aged 18 or over
- Non-alcoholic fatty liver disease (NAFLD) suspected by doctors, based on a past liver biopsy, a planned liver biopsy, or scans showing scarring of the liver (cirrhosis) alongside at least 2 signs of metabolic syndrome (for example a larger waist or higher weight, raised blood sugar, unhealthy blood fats, or high blood pressure)
- Drinking less than 21 units of alcohol a week for men, or 14 units a week for women, over the last 6 months, with no history of heavy drinking in the past 5 years
Who may not be able to
- Not able or not willing to give informed consent
- Drinking more than about 21 units a week (men) or 14 units a week (women) in the last 6 months, or a history of heavy drinking in the past 5 years
- Having or having had type 1 diabetes
- Having any other long-term liver disease besides NAFLD
- Recent or current use of certain medicines that can cause fatty liver (for example long-term steroid tablets, amiodarone, methotrexate, tamoxifen, tetracycline, high-dose oestrogens or valproic acid)
- Anything that makes a liver biopsy unsafe
- A recent change (within 3 months) in dose or start of certain supplements or medicines, such as high-dose vitamin E, betaine, ursodeoxycholic acid, silymarin or pentoxifylline
- Not speaking English and not able to access an interpreter, because the study collects diet, exercise and symptom information
- Not meeting the entry criteria, or the study team judging the person unsuitable
What taking part involves
- • This is a registry, not a treatment trial — Not stated whether any treatment is given; ask the trial team
Time commitment: Not stated — ask the trial team about visits, duration and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years to 100 Years
- Who
- All
- Number of participants
- 10,000
- Started
- 2015-05-01
- Last checked
- 2023-01
Plain English Summary
What is this study?
- • Testing a new treatment for nafld
- • Clinical study - 10,000 participants
- • 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
Who can take part?
- • Ages 18 Years to 100 Years
- • Diagnosed with nafld
Where?
- • Birmingham - University Hospitals Birmingham Nhs Foundation Trust
- • Cambridge - Addenbrooke'S Hospital
- • Gateshead - Queen Elizabeth Hospital
- • Hull - Hull Royal Infirmary
- • +7 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
The European NAFLD Registry is a major international collaboration between clinical academics at leading universities across Europe, initially established with funding from the European Association for the Study of the Liver and through the EU FP7, H2020 and IMI2 schemes to the projects FLIP (Fatty Liver Inhibition of Progression), EPoS (Elucidating Pathways of Steatohepatitis) and LITMUS (Liver Investigation: Testing marker Utility in Steatohepatitis). 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 100 Years
- Who can join: All genders
What the study is looking for
- ✓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...
- ✓Patient with radiological evidence of cirrhosis (in absence of an alternative aetiology) plus presence of ≥2...
See the full criteria
Where Is This Study? (11 UK sites)
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 NE7 7DN, 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
How to Get in Touch
Quentin M Anstee, MBBS, PhD
Sponsor contactCONTACT
Kristy L Wonders, BA, MLitt
Sponsor contactCONTACT
