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A registry for studying Non-Alcoholic Fatty Liver Disease in Europe

The European NAFLD Registry

Observational Newcastle University · NCT04442334

This study is collecting health information and samples from people with Non-Alcoholic Fatty Liver Disease to learn more about the disease and find better ways to track its progress.

Quick facts

Study typeObservational
Enrollment10000 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNewcastle University Academic / other
Drugs / interventionsmethotrexate
Locations37 sites (Antwerp and 36 other locations)
Trial IDNCT04442334 on ClinicalTrials.gov

What this trial studies

The European NAFLD Registry is an observational study that collects clinical data and biological samples from patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH). It aims to understand the disease's natural history, clinical phenotype, and outcomes, while also developing and validating biomarkers for disease progression. The study involves collaboration among leading universities and medical centers across Europe, utilizing comprehensive datasets to support translational research into the pathophysiology of NAFLD. Patients may also participate in nested sub-studies with additional consent.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with clinically suspected NAFLD based on specific histological, biochemical, or radiological evidence.

Not a fit: Patients without any evidence of NAFLD or those with alternative liver disease etiologies may not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could lead to improved detection and monitoring of NAFLD and its progression, ultimately enhancing patient care.

How similar studies have performed: Other studies focusing on NAFLD and NASH have shown promise in understanding disease mechanisms and developing biomarkers, indicating that this approach is supported by prior research.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥18 years.
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

1. Refusal or inability (lack of capacity) to give informed consent.
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.
9. Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.

Where this trial is running

Antwerp and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions NAFLDNASHNASH - Nonalcoholic SteatohepatitisFibrosis, LiverSteatosis of LiverHepatocellular CarcinomaCardiovascular DiseasesType 2 Diabetes
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.