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

December 13, 2025 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France
        • Centre Hospitalier Universitaire Dijon Bourgogne
      • Nantes, France
        • CHU de Nantes
      • Pierre-Bénite, France
        • Hôpital Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of individual F0 to F4 stage of fibrosis
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibroscan
Time Frame: 6 months
The presence of liver stiffness measured using Fibroscan (VCTE) ≥ 7 kPa.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Cyrielle CAUSSY, MD, Hospices civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2020

Primary Completion (Actual)

October 28, 2023

Study Completion (Actual)

September 11, 2024

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 15, 2020

First Posted (Actual)

June 17, 2020

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL20_0033

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Alcoholic Fatty Liver Disease

Clinical Trials on Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe