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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04435054

Collaborator

(none)

1,000

Enrollment

Locations

Arm

35.1

Anticipated Duration (Months)

333.3

Patients Per Site

9.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease	Diagnostic Test: Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis.	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Screening for NAFLD-related Advanced Fibrosis in High Risk popuLation: Optimization of the Diabetology Pathway Referral Using Combinations of Non-invAsive Biological and elastogRaphy paramEters

Actual Study Start Date :

Oct 28, 2020

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Non invasive tests	Diagnostic Test: Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis. Non-invasive blood biological tests - NAFLD Fibrosis Score, FIB-4, Fibrotest, FibrometerNAFLD Non-invasive imaging: - Transient elastography (FibroScan), Shear Wave imaging, Magnetic resonance imaging (MRI-PDFF and MRE) in a subgroup of participants.

Arm

Intervention/Treatment

Other: Non invasive tests

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

Non-invasive blood biological tests - NAFLD Fibrosis Score, FIB-4, Fibrotest, FibrometerNAFLD Non-invasive imaging: - Transient elastography (FibroScan), Shear Wave imaging, Magnetic resonance imaging (MRI-PDFF and MRE) in a subgroup of participants.

Outcome Measures

Primary Outcome Measures

Presence of individual F0 to F4 stage of fibrosis [6 months]
The presence of individual F0 to F4 stage of fibrosis as defined by histological stage in the liver biopsy using the NASH CRN Scoring System.

Secondary Outcome Measures

Fibroscan [6 months]
The presence of liver stiffness measured using Fibroscan (VCTE) ≥ 7 kPa.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.