Screening for MASLD-related Advanced Fibrosis in Type 2 Diabetes

ConditionsSteatotic Liver Disease Fibrosis of Liver

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Collaborative care pathways group
Procedure/Surgery
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
Control group without intervention
Procedure/Surgery
Hepatic AF screening in patients with T2D in private diabetes clinics according to routine care

Treatment groups

1,714 Participants

are divided into 2 treatment groups

Group A: Collaborative care pathways groupExperimental treatment 1 intervention

Group B: Control group without interventionOther 1 intervention

Trial outcomes

Primary outcomes

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

Time frame