This study aims to address the following key scientific question by establishing a large-scale, high-standard clinical cohort: the independent contribution of MASLD and its progression to liver fibrosis on cardiovascular outcomes in patients with T2DM, after excluding the confounding effects of traditional cardiovascular risk factors. Its technical value lies in utilizing prospective follow-up data combined with a multivariable competing risks model to develop and validate a cardiovascular risk prediction and early warning system tailored for Chinese populations with T2DM complicated by MASLD. Clinically, the findings will provide interdisciplinary evidence-based support for endocrinology and cardiology, helping clinicians identify high-risk individuals and prevent cardiovascular events through early intervention targeting hepatic metabolic disorders. This has significant implications for reducing overall mortality among diabetic patients in China and alleviating the public health burden.
Study Type
OBSERVATIONAL
Enrollment
7,000
MingWei Wang
Hanzhou, Zhejiang, China
Major Adverse Cardiovascular Events (MACE)
The occurrence of major adverse cardiovascular events during the 5-year follow-up period, including: Cardiovascular death Non-fatal myocardial infarction Non-fatal ischemic or hemorrhagic stroke Hospitalization for heart failure
Time frame: Baseline to 5 years
Progression of Liver Fibrosis
Changes in liver fibrosis severity assessed by liver stiffness measurement (LSM), Fibrosis-4 index (FIB-4), and controlled attenuation parameter (CAP).
Time frame: Every 12 months up to 5 years
All-cause Mortality
Death from any cause during follow-up.
Time frame: Baseline to 5 years
Renal Outcomes
Development of end-stage kidney disease (ESKD), decline in estimated glomerular filtration rate (eGFR), or significant increase in urinary albumin-to-creatinine ratio (UACR).
Time frame: Time Frame: Baseline to 5 years
Cardiovascular Imaging Progression
Changes in carotid intima-media thickness (CIMT), carotid plaque burden, left ventricular structure and function, and coronary artery stenosis.
Time frame: Annually for 5 years
Liver-related Clinical Outcomes
Development of cirrhosis, hepatocellular carcinoma, liver failure, or liver-related death.
Time frame: Baseline to 5 years
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