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

NCT ID: NCT04435054

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-28

Study Completion Date

2024-09-11

Brief Summary

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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

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Conditions

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Non-Alcoholic Fatty Liver Disease

Keywords

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NAFLD Type 2 diabete Obesity Advanced fibrosis Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Non invasive tests

Group Type OTHER

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

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cyrielle CAUSSY, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Centre Hospitalier Universitaire Dijon Bourgogne

Dijon, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

Hôpital Lyon Sud

Pierre-Bénite, , France

Site Status

Countries

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France

References

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Caussy C, Verges B, Leleu D, Duvillard L, Subtil F, Abichou-Klich A, Hervieu V, Milot L, Segrestin B, Bin S, Rouland A, Delaunay D, Morcel P, Hadjadj S, Primot C, Petit JM, Charriere S, Moulin P, Levrero M, Cariou B, Disse E. Screening for Metabolic Dysfunction-Associated Steatotic Liver Disease-Related Advanced Fibrosis in Diabetology: A Prospective Multicenter Study. Diabetes Care. 2025 Jun 1;48(6):877-886. doi: 10.2337/dc24-2075.

Reference Type RESULT
PMID: 39887699 (View on PubMed)

Other Identifiers

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69HCL20_0033

Identifier Type: -

Identifier Source: org_study_id