Screening for MASLD-related Advanced Fibrosis in Type 2 Diabetes

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1714 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2028-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Steatotic Liver Disease Fibrosis of Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Collaborative care pathways group

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).

Group Type EXPERIMENTAL

Collaborative care pathways group

Intervention Type 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

Control group without intervention

Current clinical routine practice with no specific intervention

Group Type OTHER

Control group without intervention

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No