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RECRUITING
NCT06567990
NA

Type 2 DIAbeTes With NAFLD: innOvative Biomarkers of Disease progressioN and clInical outComes

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

Type 2 diabetes (T2DM) patients are at high-risk for advanced fibrosis (AF) due to non-alcoholic fatty liver disease (NAFLD), recently renamed Metabolic dysfunction-Associated Liver Disease (MASLD). Thus, patients with T2DM are recognized as a priority target for the screening of MASLD-related advanced fibrosis and a systematic screening for AF is currently recommended in T2DM patients using FIB-4 and liver stiffness measurement (LSM).The main objective of the project is to investigate the ability of baseline non-invasive biomarkers to discriminate patients with a progression of MASLD from patients without progression of MASLD among patients with T2DM and to investigate the association between clinical outcomes related to the natural evolution of MASLD and T2DM and baseline biomarkers.

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2024-09-25

Completion Date

2027-05-25

Last Updated

2026-01-28

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Non-invasive test for the screening of MASLD-related advanced fibrosis in patients with T2D.

* Non-invasive blood biological tests = NAFLD Fibrosis Score, FIB-4 score, FNI score, Agile3+ score, FASTscore, ELF, Fibrotest, Fibrometer if performed in clinical care * Non-invasive imaging = Transient elastography (FibroScan), Questionnaire assessing alcohol consumption

Locations (4)

Service Endocrinologie, Diabétologie, Maladies Métaboliques et Nutrition

Dijon, France

Endocrinologie, Diabète et Nutrition in Louis PRADEL Hospital

Lyon, France

Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition CIC Endocrino-Nut

Nantes, France

Service d'Endocrinologie, Diabète et nutrition

Pierre-Bénite, France