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ClinicalTrials.gov ID

NCT07270822

Lead Sponsor

Hospices Civils de LyonOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

1,714Estimated

Last Update Posted

Apr 3, 2026Actual

Start Date

May 1, 2026Estimated

Primary Completion Date

Mar 1, 2029Estimated

Completion Date

Mar 1, 2029Estimated

Official Title

Implementation of a Systematic Screening for MASLD-related Advanced fibrosiS for Patients With Type 2 Diabetes folLoweD by DIABetologists

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.

• Steatotic Liver Disease
• Fibrosis of Liver

• Collaborative care pathways group
• Control group without intervention

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Hospices Civils de LyonOTHER

aclavier001@gmail.com+33 4 72 41 70 02

dr.marine.benoit@gmail.com+33 4 72 41 70 02

drbogenmann@gmail.com

docteurmcg@gmail.com+33 6 13 65 00 10

dr.audreyvillard@gmail.com+33 6 72 08 19 88

drjoncourmills@gmail.com+33 4 72 41 70 02

secretariat@endoclyon.fr+33 4 69 98 20 87

claire.damatte-fauchery@orange.fr+33 6 79 89 57 31

sylviemarsot@neuf.fr+33 6 41 67 71 10