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

Civil Hospices of Lyon

Status

Completed

Conditions

Non-Alcoholic Fatty Liver Disease

Treatments

Diagnostic Test: Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis.

Study type

Interventional

Funder types

Other

Identifiers

NCT04435054

69HCL20_0033

Details and patient eligibility

About

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.

Enrollment

1,000 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.