The European NAFLD Registry

Launched by NEWCASTLE UNIVERSITY · Jun 19, 2020

Keywords

ClinConnect Summary

The European NAFLD Registry is a clinical study aimed at understanding Non-Alcoholic Fatty Liver Disease (NAFLD) and its more severe form, Non-Alcoholic Steatohepatitis (NASH). The study will gather information about how these conditions develop and progress over time. Researchers hope to identify the different factors that affect each patient's experience with the disease and to find reliable tests that can help monitor how the disease changes from milder cases to more serious ones, like liver fibrosis or cirrhosis.

To participate, individuals must be at least 18 years old and have signs of NAFLD, which may include a liver biopsy showing fat in the liver or specific imaging results. Participants should have a history of low alcohol consumption and may have other health conditions related to metabolism, such as obesity or type 2 diabetes. Those who join the study will be asked to provide information about their health and lifestyle, which will help researchers gather valuable data. Remember, one important requirement is that participants should be able to understand English or have access to an interpreter.

Gender

ALL

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 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.