Status:
RECRUITING
The European NAFLD Registry
Lead Sponsor:
Newcastle University
Collaborating Sponsors:
Newcastle-upon-Tyne Hospitals NHS Trust
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
NAFLD
NASH
Eligibility:
All Genders
18-100 years
Brief Summary
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 Fat...
Detailed Description
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 fo...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Exclusion Criteria
- Refusal or inability (lack of capacity) to give informed consent.
- 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.
- 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).
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT04442334
Start Date
May 1 2015
End Date
December 31 2030
Last Update
January 6 2023
Active Locations (37)
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1
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
2
Helsinki University Hospital
Helsinki, Finland
3
Le Centre de Recherche Clinique (CRC) du CHU d'Angers
Angers, France, 49933
4
Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière
Paris, France, 75013