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Taking people in SpainNo phase

Observational registry following people with fatty liver disease across Europe

Records clinical course and outcomes of adults with fatty liver disease and steatohepatitis.

Key facts

Who runs it
Newcastle University
Where
Barcelona, Donostia / San Sebastian, Majadahonda, Santander, Seville, and Valladolid, SpainSee the 6 sitesAlso in 11 other countries, 31 sites
Trial code
Registry title
The European NAFLD Registry
Status
Recruiting
People taking part
10,000 people, planned
Started
1 May 2015
Expected to end
31 Dec 2030
Type of study
Observational, 3 groups
Record updated
6 January 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with suspected non-alcoholic fatty liver disease (NAFLD). Participants take part in an observational registry that follows the disease over time.

Age
18 years or older (up to 100 years)
Sex
All sexes
Disease stage
Suspected NAFLD shown by a past or planned liver biopsy, or by scans showing cirrhosis plus at least 2 signs of metabolic syndrome.
Earlier treatment
Must not have recently started or changed vitamin E (400 IU/day or more), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline in the last 3 months. Must not have used drugs that cause fatty liver in the last 12 months.

Main reasons for not taking part

  • Drinks more than about 21 units a week (men) or 14 units a week (women), or drank heavily for a long time in the past 5 years
  • Type 1 diabetes, now or in the past
  • Any other chronic liver disease besides NAFLD
  • Any reason a liver biopsy cannot be done
  • Cannot speak English and has no interpreter

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • 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
  • History or presence of Type 1 diabetes mellitus
  • Presence of any other form of chronic liver disease except NAFLD
  • Refusal or inability (lack of capacity) to give informed consent
  • Any contra-indication to liver biopsy
  • 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
  • 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
  • Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 100 years old?

Where in Spain

Also in 11 other countries, 31 sites

  • Vall d'Hebron University HospitalBarcelona, SpainContact: Salva Augustin, MDTaking people
  • Biodonostia Health Research InstituteDonostia / San Sebastian, SpainContact: Jesus Banales, PhDTaking people
  • Puerta de Hierro University HospitalMajadahonda, SpainTaking people
  • Marqués de Valdecilla University HospitalSantander, SpainContact: Javier Crespo, MDTaking people
  • Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University HospitalSeville, SpainContact: Manuel Romero-Gomez, MDTaking people
  • HU Clínico de ValladolidValladolid, SpainContact: Rocío Aller de la Fuente, MD, PhDTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • 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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The European NAFLD Registry
Plain-language title
Observational registry following people with fatty liver disease across EuropeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04442334, who can take part
Record updated
6 January 2023