THE FRENCH NATIONAL NAFLD COHORT (FRench pAtients With MEtabolic Steatosis)

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jun 7, 2021

Keywords

ClinConnect Summary

The French National NAFLD Cohort study is looking into a condition called Nonalcoholic Fatty Liver Disease (NAFLD) and its more severe form, Nonalcoholic Steatohepatitis (NASH). The goal of this study is to understand the different factors that affect how severe the disease can be at the time of diagnosis and how it may progress over time. By studying these factors, researchers hope to better identify patients with varying levels of disease severity and predict how their condition might change, particularly regarding liver damage known as fibrosis and cirrhosis.

To participate in this study, individuals must be at least 18 years old and have a confirmed diagnosis of NAFLD. They should also be covered by French social security and be able to provide written consent to join the study. Unfortunately, individuals who drink large amounts of alcohol, have certain other liver diseases, or have recently taken specific medications that could affect the liver cannot participate. The study is not yet recruiting, but once it begins, participants can expect to undergo evaluations that will help researchers gain important insights into NAFLD and improve future treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years
• • 2. Patients with a confirmed diagnosis of NAFLD
• • 3. Patients affiliated to French social security
• • 4. Written informed consent signed by the patient
• Exclusion Criteria:
• • 1. Refusal or inability (lack of capacity) to give informed consent.
• • 2. Average alcohol ingestion greater than 21/14 units/week (males/females) in the 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-French speaking/unable to access an interpreter.
• • 9. Patients judged by the investigator to be unsuitable for inclusion in the study (e.g. judged by the physician as unlikely to be compliant with the study protocol).
• • 10. Pregnant or breastfeeding women
• • 11. Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom