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The goal of this observational study is to learn about the molecular mechanisms underlying cardiovascular complications in individuals with type 2 diabetes (T2DM) and how they differ from healthy individuals. The study will also identify biomarkers and potential therapeutic targets for better managing diabetes-related heart disease.
The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Diabetes or Cardiovascular Complications Group | This group consists of individuals who do not have diabetes or cardiovascular complications. They serve as a control group for comparison with the other cohorts. Participants in this group will undergo the same clinical assessments and provide biological samples for multi-omics analysis to identify molecular differences between individuals with and without T2DM and cardiovascular issues. | ||
| T2DM without Cardiovascular Complications Group | This group includes individuals diagnosed with type 2 diabetes but without any cardiovascular complications at the time of enrollment. The goal is to explore the molecular effects of T2DM on biological networks independent of cardiovascular issues. Participants will provide blood samples for genomic, transcriptomic, and proteomic analysis and undergo standard clinical tests, including echocardiograms and measurements of vascular health. | ||
| T2DM with Cardiovascular Complications Group | This group consists of T2DM patients who have developed cardiovascular complications, such as coronary artery disease or heart failure. This cohort will be studied to identify how cardiovascular complications further alter molecular networks in individuals with T2DM. Blood samples will be analyzed for genomics, gene expression, and protein profiles, and participants will undergo additional clinical assessments, including vascular imaging and ankle-brachial index measurements. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Major Adverse Cardiovascular Events (MACE) | Description: To assess the occurrence of major adverse cardiovascular events (MACE), including myocardial infarction, stroke, or heart failure, over the 2-year follow-up period. Time Frame: 12 months and 24 months follow-up. Measurement Method: Clinical assessments through medical records, including hospitalizations, laboratory data, echocardiograms, and imaging techniques (e.g., vascular imaging, ABI, carotid ultrasound). | From enrollment to the end of treatment at 12 months and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of patients who have undergone coronary angiography at the Second Xiangya Hospital of Central South University for various reasons. The study will involve individuals aged between 20 and 70 years who meet the inclusion criteria, including providing informed consent and the ability to supply complete medical history and biological samples. The population will encompass individuals with varying levels of cardiovascular health, including those with and without cardiovascular complications, to enable comprehensive multi-omics analysis and long-term cardiovascular event tracking.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shi Tai | Contact | 18711083824 | taishi2017@csu.edu.cn |
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all IPD that underlie results in a publication
Beginning 3 months and ending 3 years after the publication of results
To access the IPD and supporting information, interested parties should contact the principal investigator.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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The study will collect several types of biological samples from participants, but all samples will be destroyed immediately after testing. These include:
Blood Samples (5 mL per participant): Blood samples will be collected for genomics, transcriptomics, and proteomics analysis. The blood will be processed to isolate plasma, serum, and peripheral blood mononuclear cells (PBMCs) for the following purposes: