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

NCT04435054 | Completed

• 1 other identifier: 69HCL20_0033
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

NAFLD; Type 2 diabete; Obesity; Advanced fibrosis; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fibroscan

  6 months

Study Arms (1)

Non invasive tests

OTHER

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

Interventions

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

Non invasive tests

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Centre Hospitalier Universitaire Dijon Bourgogne

Dijon, France

Location

CHU de Nantes

Nantes, France

Location

Hôpital Lyon Sud

Pierre-Bénite, France

Location

Related Publications (1)

• 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.

  PMID: 39887699 RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity; Fibrosis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Cyrielle CAUSSY, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 17, 2020
• Study Start: October 28, 2020
• Primary Completion: October 28, 2023
• Study Completion: September 11, 2024
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (3)