MingWei Wang
Hanzhou, Zhejiang, 310000, China
NCT Number: NCT07706010
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Hanzhou, Zhejiang, 310000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
2.Meet the diagnostic criteria for type 2 diabetes mellitus (T2DM) according to the Chinese Guideline for the Prevention and Treatment of Type 2 Diabetes (2022 edition), with a confirmed diagnosis for at least 3 months;
3.Meet the diagnostic criteria for metabolic dysfunction-associated steatotic liver disease (MASLD) according to the *Chinese Guideline for the Diagnosis and Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease (2024 edition)*, with preliminary assessment including liver enzymes (ALT/AST), liver ultrasound, and non-invasive fibrosis markers (FIB-4, LSM), and exclusion of other liver diseases;
4.Willing to participate in this study and provide written informed consent;
5.Able to cooperate with baseline survey and long-term follow-up (i.e., expected to reside in the study area during the follow-up period, without severe cognitive impairment, movement disorders, or other conditions that would interfere with follow-up).
Exclusion criteria
2.Concomitant severe cardiovascular or cerebrovascular disease, end-stage renal disease (CKD stage 5), malignant tumor, severe infection, etc., with an estimated life expectancy <5 years;
3.Current use of medications that may significantly affect liver metabolism or glucose metabolism (other than routine glucose-lowering, lipid-regulating, or hepatoprotective agents) that cannot be adjusted;
4.Pregnant or lactating women, or those planning to become pregnant in the near term;
5.Severe mental illness or cognitive impairment that prevents cooperation with surveys and follow-up;
6.Refusal to sign informed consent, or inability to comply with study procedures.
Time frame: Baseline to 5 years
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: Every 12 months up to 5 years
Changes in liver fibrosis severity assessed by liver stiffness measurement (LSM), Fibrosis-4 index (FIB-4), and controlled attenuation parameter (CAP).
Time frame: Baseline to 5 years
Death from any cause during follow-up.
Time frame: Time Frame: Baseline to 5 years
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: Annually for 5 years
Changes in carotid intima-media thickness (CIMT), carotid plaque burden, left ventricular structure and function, and coronary artery stenosis.
Time frame: Baseline to 5 years
Development of cirrhosis, hepatocellular carcinoma, liver failure, or liver-related death.
Contact information is provided by the study sponsor or research team.
The Affiliated Hospital of Hangzhou Normal University
Other
A Cohort Study on Cardiovascular Risk in Type 2 Diabetes Mellitus Complicated With Metabolic Dysfunction-Associated Fatty Liver Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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