Screening for MASLD-related Advanced Fibrosis in Type 2 Diabetes (MASLD-DIAB)
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Details and patient eligibility
About
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.
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,714 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Cyrielle CAUSSY, MD, PhD; Dominique DELAUNAY, PhD
Data sourced from clinicaltrials.gov
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