Type 2 Diabetes (T2D) Clinical Trials

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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients with T2D and meeting the other inclusion criteria of the NAFLD-Care study:

• Patient aged between 40 and 80 years old,

• Patient with hepatic steatosis determined by conventional abdominal ultrasound as defined by the EASL/EASO/EASD European guidelines.

• Patient who agrees to be included in the study and who signs the informed consent form,

• Patient affiliated to a healthcare insurance plan.

Locations
Other Locations
France
Service Endocrinologie, Diabétologie, Maladies Métaboliques et Nutrition
RECRUITING
Dijon
Endocrinologie, Diabète et Nutrition in Louis PRADEL Hospital
RECRUITING
Lyon
Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition CIC Endocrino-Nut
RECRUITING
Nantes
Service d'Endocrinologie, Diabète et nutrition
RECRUITING
Pierre-bénite
Contact Information
Primary
Cyrielle CAUSSY, Pr
cyrielle.caussy@chu-lyon.fr
4 78 86 44 48
Backup
Dominique DELAUNAY, Dr
Dominique.delaunay@chu-lyon.fr
4 72 11 00 64
Time Frame
Start Date: 2024-09-25
Estimated Completion Date: 2027-05-25
Participants
Target number of participants: 500
Treatments
Other: Patients with T2D and MASLD without advanced fibrosis (AF) (COHORT A)
Patients with T2D and MASLD without advanced fibrosis (AF) at baseline in the NAFLD-Care study.
Other: Patients with T2D and MASLD, without diagnosis of cirrhosis (COHORT B)
Patients with T2D and MASLD with presence of advanced fibrosis (AF) and without cirrhosis at baseline in the NAFLD-Care study
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov