Screening for MASLD-related Advanced Fibrosis in Type 2 Diabetes

NCT07270822 | Not Yet Recruiting

• 1 other identifier: 69HCL24_0848
• Study Type: interventional
• Target: 1,714
• Locations: 1 country
• Sites: 10

Brief Summary

Metabolic dysfunction-associated steatotic liver disease (MASLD) affects approximately 25% of the global adult population, 25-30% of whom suffer from metabolic dysfunction-associated steatohepatitis (MASH), increasing the risk of progression to advanced fibrosis (AF) (fibrosis stage F3 or cirrhosis F4). Screening for AF is justified because it is associated with an increased risk of overall, hepatic, and cardiovascular mortality and therefore constitutes a public health issue. Patients with type 2 diabetes (T2D) are identified as a priority target for screening because they are at high risk of AF related to MASLD. The recommendations of the French Association for the Study of the Liver 2020 (afef.asso.fr), the European Association for the Study of the Liver (2024), the American Association of Clinical Endocrinology (2022), and the American Association of Diabetes (2025) all recommend a two-step screening process involving the FIB-4 biological score, followed by transient elastography (TE) if the FIB-4 score is \> or = 1.30. Finally, if the TE is ≥8 kPa, the patient is considered to be at intermediate/high risk of AF requiring specialized care to confirm the diagnosis and implement appropriate management, including semi-annual screening for hepatocellular carcinoma in cases of cirrhosis Despite these recommendations, their application in clinical practice remains difficult and requires multidisciplinary collaboration between diabetologists and hepatologists, and between community and hospital sectors, particularly to access TE measures. Since 2018, the Lyon Sud diabetes department (Hospices Civils de Lyon) has implemented an in-hospital AF screening program using TE for T2D patients. However, this screening by private diabetologists has not yet been implemented, mainly due to the lack of a standardized care pathway and difficulty in accessing TE measurements. HYPOTHESIS The implementation of systematic and standardized AF screening in private diabetes practices, in two stages and using ET in diabetes care in accordance with recommendations, would significantly increase the identification of patients with AF and thus improve their access to specialized services and appropriate care.

Conditions

Steatotic Liver Disease; Fibrosis of Liver

Keywords

Metabolic dysfunction-associated steatotic liver disease; hepatic transient elastography; hepatic fibrosis; type 2 diabetes mellitus; screening; non-invasive tests

Outcome Measures

Primary Outcomes (1)

• Proportion of T2D patients eligible for screening and having undergone AF screening according to the recommendations including assessment of the FIB-4 score, measurement of TE if indicated, and referral for specialized care if required

  1. Calculation of the FIB-4 score \<1.30 (automatic calculation by the medical analysis laboratory or calculated by the liberal diabetologist). 2. Calculation of the FIB-4 score ≥ 1.30 (automatic calculation by the medical analysis laboratory or calculated by the liberal diabetologist) and realization of a measurement of hepatic TE with either: * TE measurement less than 8 kPa OR * Measurement of TE greater than or equal to 8kPa and referral for specialized care to a private hepatologist, a hospital hepatology department or the Institute of Hepatology of Lyon at HCL According to the recommendations of the EASL (European Association for the Study of the Liver) and the AFEF (French Association for the Study of the Liver), screening includes both the calculation of the FIB-4 score, a transient (TE) measurement, and referral, if indicated, for specialized care. ET and FIB-4 measurements cannot be separated

  Between 6 and 12 months following inclusion

Secondary Outcomes (41)

• Proportion of patients undergoing transient elastography (TE) measurement

  Between 6 and 12 months following inclusion

• Proportion of patients referred for specialized consultation for the management of MASLD

  Between 6 and 12 months following inclusion

• Proportion of patients with TE values ≥ 8 kPa among those referred to specialized care.

  Between 6 and 12 months following inclusion

• Time interval between successive steps of the screening pathway: FIB-4 assessment, TE measurement, and specialized consultation for the management of MASLD.

  Between 6 and 12 months following inclusion

• Number of diabetologists not initially participating in implementing the screening pathway (FIB-4 ± TE),

  Through the inclusion period (after implementation of the new care pathway), an average of 7 months

Study Arms (2)

Collaborative care pathways group

EXPERIMENTAL

Collaborative development of a care pathway for the implementation of a systematic and standardized screening for hepatic AF in patients with T2D in private diabetes clinics. The care pathway will include calculation of the FIB-4 score and transient elastography measurement performed in diabetes clinics if FIB-4≥1.30, in accordance with the recommendations of the French Association for the Study of the Liver (AFEF) and the European Association for the Study of the Liver (EASL).

Procedure: Collaborative care pathways group

Control group without intervention

OTHER

Current clinical routine practice with no specific intervention

Procedure: Control group without intervention

Interventions

Collaborative care pathways group PROCEDURE

CO-CONSTRUCTION OF THE CARE PATHWAY: Participatory approach according to scientific literature, professional practices, and experience of both healthcare providers and patients. Establishment of a working group (hospital endocrinologists, hepatologists, private practice diabetologists, representatives of patients with diabetes followed in the participating centers) to define implementation modalities, professional training, communication and information transfer between professionals, and to ensure a smooth care pathway without overloading the health system . IMPLEMENTATION: Definition of patient care pathway Training of private diabetologists to integrate FIB-4 and TE measurement into their practices Provision of the FibroScan® Monitoring of patients included in the screening program and of the number of TE measurements performed Validation of TE measurements ≥ 8 kPa in a specialized center Definition of referral procedures for patients towards the specialized center

Collaborative care pathways group

Control group without intervention PROCEDURE

Hepatic AF screening in patients with T2D in private diabetes clinics according to routine care

Control group without intervention

Eligibility Criteria

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

You may qualify if:

• Adult patient, male or female
• Type 2 diabetic patient, followed by a diabetologist in private practice participating in the study
• Patient affiliated to a French or European healthcare insurance
• Patient who agrees to be included in the study and who signs the informed consent form

You may not qualify if:

• Evidence of advanced fibrosis (F3 or F4 fibrosis based on the results from previous liver biopsy F3 ou F4 or evidence of cirrhosis).
• Evidence of other causes of chronic liver disease
• Patient who does not understand French/ is unable to give consent,
• Patient already included in a trial who may interfere with the study
• The subject is a pregnant or nursing female
• Minor patient
• Patient deprived of liberty,
• Patient admitted to a health or social establishment for purposes other than research
• Mentally unbalanced patients, under supervision or guardianship,
• Patient undergoing psychiatric care
• Patient not affiliated to a healthcare insurance plan
• Patient already included in this screening program in the previous 12 months

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (10)

Diabetology private center

Caluire-et-Cuire, 69300, France

Location

Diabetology private center

Lyon, 69001, France

Location

Diabetology private center

Lyon, 69001, France

Location

Diabetology private center

Lyon, 69002, France

Location

Diabetology private center

Lyon, 69005, France

Location

Diabetology private center

Lyon, 69009, France

Location

Diabetology private center

Lyon, 69009, France

Location

Diabetology private center

Lyon, 69009, France

Location

Diabetology private center

Saint-Maurice-l'Exil, 38550, France

Location

Diabetology private center

Sathonay-Camp, 69580, France

Location

MeSH Terms

Conditions

Liver Cirrhosis; Diabetes Mellitus, Type 2

Interventions

Control Groups; Methods

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design

Central Study Contacts

Cyrielle CAUSSY, MD, PhD

CONTACT

+33 4 78 86 44 48; cyrielle.caussy@chu-lyon.fr

Dominique DELAUNAY, PhD

CONTACT

+33 4 72 11 00 64

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized cluster study with two parallel arms: * Experimental group: Clusters or private diabetes clinics (five centers) in which a systematic and standardized screening pathway for hepatic AF in patients with T2D has been implemented: calculation of the FIB-4 score and transient elastography measurement performed in diabetes care if FIB-4≥1.30, in accordance with the recommendations of the French Association for the Study of the Liver (AFEF) and the European Association for the Study of the Liver (EASL) . * Control group: Clusters or private diabetes practices in which no specific intervention will be deployed (5 centers)

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: December 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-11

Locations

FR (10)