Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567990
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Type 2 DIAbeTes With NAFLD innOvative Biomarkers of Disease progressioN and clInical outComes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Type 2 DIAbeTes With NAFLD innOvative Biomarkers of Disease progressioN and clInical outComes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIATONIC
Brief 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 LSMThe 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
Detailed Description:
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 Hence these Non-Invasive Tests NITs are expected to be integrated in the management of T2DM in a near future Indeed diabetologists are becoming more aware of the need for liver assessment in patients with T2DM recently reinforced by recent clear recommendations supporting the use of non-invasive test NITs such as LSM for the detection of liver fibrosis Several studies indicate that MASLD increases the risk of T2DM complications However there are very limited data and no prospective longitudinal data assessing the progression of MASLD and relevant clinical outcomes in T2DM patients included in liver screening using these NITs This provides a unique opportunity to better stratify T2DM and to understand the heterogeneity among patients with T2DM by defining patients profiles linked the progression of MASLD and relevant clinical outcomes
Therefore 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
Therefore 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None