Screening for NAFLD-related Advanced Fibrosis in High Risk Population in Diabetology.

  • STATUS
    Recruiting
  • End date
    Oct 26, 2023
  • participants needed
    1000
  • sponsor
    Hospices Civils de Lyon
Updated on 26 January 2021

Summary

Nonalcoholic fatty liver disease (NAFLD) is being recognized as one of the most prevalent causes of chronic liver disease worldwide. The current strategy proposed by the EASL/EASO/EASD European guidelines for the screening of nonalcoholic fatty liver disease (NAFLD) in high-risk population such as type 2 diabetes and patients with obesity leads to an over-referral in hepatology clinics. The proposed study will investigate the optimal strategy for the screening of NAFLD-related advanced fibrosis in patients at high risk of fibrotic NAFLD, such as patients with T2DM or obesity by maximizing the positive predictive value (PPV) using non-invasive blood and elastography-based biomarkers in endocrinology/diabetology clinics in order to reduce the over-referral to hepatology clinics.

Details
Treatment Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis.
Clinical Study IdentifierNCT04435054
SponsorHospices Civils de Lyon
Last Modified on26 January 2021

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Eligibility

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Inclusion Criteria

Is your age between 40 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Nonalcoholic Steatohepatitis (NASH) or Non Alcoholic Fatty Liver Disease or NAFLD or non-alcoholic fatty liver or Non-alcoholic Fatty Liver Disease or...?
Do you have any of these conditions: Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis (NASH) or NAFLD or Non Alcoholic Fatty Liver Disease or Non-alcoholic Fatty Liver Dis...?
Do you have any of these conditions: Nonalcoholic Fatty Liver Disease or non-alcoholic fatty liver or Non-alcoholic Fatty Liver Disease or Non Alcoholic Fatty Liver Disease or Nonalcoholi...?
Patient aged between 40 and 80 years old
Patients with diagnosis of T2DM or obesity (defined according to World Health Organization as a BMI 30 kg/m2)
Patient with hepatic steatosis determined by conventional abdominal ultrasound as defined by the EASL/EASO/EASD European guidelines
Patient who agrees to be included in the study and who signs the informed consent form
Patient affiliated to a healthcare insurance plan

Exclusion Criteria

Evidence of other causes of chronic liver disease
History of ingestion of medications known to produce steatosis in the previous 6 months
Evidence of cirrhosis or previously known cirrhosis based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices
Presence of regular and/or excessive use of alcohol (defined as >30g/day for males and >15g/day for females) for a period longer than 2 years at any times in the last 10 years
The subject is a pregnant or nursing female
Life expectancy less than 5 years
History of known HIV infection
History of type 1 diabete
BMI 40 kg/m2
Mentally unbalanced patients, under supervision or guardianship
Patient deprived of liberty
Patient who does not understand French/ is unable to give consent
Patient already included in a trial who may interfere with the study or in a period of exclusion following participation in a previous study
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