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

Non-Alcoholic Fatty Liver Disease Clinical Trial

— NAFLD-CARE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04435054
• Other study ID #: 69HCL20_0033
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: October 2023

Study information

• Verified date: July 2021
• Source: Hospices Civils de Lyon
• Contact: Cyrielle CAUSSY, MD
• Phone: 04 78 86 44 48
• Email: cyrielle.caussy[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Fibrosis
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Dijon Bourgogne	Dijon
France	CHU de Nantes	Nantes
France	Hôpital Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of individual F0 to F4 stage of fibrosis	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.	6 months
Secondary	Fibroscan	The presence of liver stiffness measured using Fibroscan (VCTE) = 7 kPa.	6 months