No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 100
Sex
Any
Study type
Observational
Participants needed
10,000 (estimated)
Sponsor
Newcastle University · Other
Who this trial is looking for
This trial is looking for adults aged 18 and over who have suspected Non-Alcoholic Fatty Liver Disease (NAFLD). Participants will provide information to help researchers understand the disease and its progression.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have symptoms or evidence of NAFLD.
My average alcohol consumption is less than 21 units per week (males) or 14 units (females).
You may not be able to join if
I cannot give informed consent.
I have had more than 21 units of alcohol per week (males) or 14 units (females) recently.
I have Type 1 diabetes.
I have another chronic liver disease.
I have used medications that cause liver issues recently.
I cannot have a liver biopsy.
I do not speak English or cannot access an interpreter.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed 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 inform…
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.
Trial Locations
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Status
Eligibility 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…
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.
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