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

Not Applicable

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Diagnostic Test: Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis.

• Registration Number: NCT04435054
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-17
• Study Start: 2020-10-28
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non invasive tests	Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis.	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Fibroscan	6 months	The presence of liver stiffness measured using Fibroscan (VCTE) ≥ 7 kPa.

Trial Locations

Locations (3)

Centre Hospitalier Universitaire Dijon Bourgogne; 🇫🇷 Dijon, France

CHU de Nantes; 🇫🇷 Nantes, France

Hôpital Lyon Sud; 🇫🇷 Pierre-Bénite, France