atherosclerosis
Conditions
Interventions
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate and sign an informed consent form; 2. Age greater than 18 years at screening, regardless of gender; 3. Diagnosed with type 2 diabetes; 4. Fasting serum LDL-C level < 3.0 mmol/L and fasting serum TG level < 5.6 mmol/L; 5. No statin use in the past month; 6. Not diagnosed with ASCVD;
Exclusion criteria
Exclusion criteria: 1. Individuals allergic to the ingredients of Xuezhikang; 2. Clear history of coronary heart disease (CAG or CTA indicating coronary artery stenosis =50%) or clinical manifestations requiring reperfusion therapy for ASCVD; 3. Active liver disease or abnormal liver function, including alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels exceeding 1.5 times the upper limit of the reference range; or significantly elevated creatinine (creatinine > 250 µmol/L); 4. Creatine kinase (CK) levels exceeding 1.5 times the upper limit of the normal reference range; 5. Concurrent use of medications affecting lipid metabolism, such as glucocorticoids, estrogens, retinoids, cyclosporine, antidepressants, vascular endothelial growth factor inhibitors, aromatase inhibitors, etc.; 6. Concurrent diseases affecting lipid metabolism, such as liver disease, nephrotic syndrome, hypothyroidism, systemic lupus erythematosus, glycogen storage disease, multiple myeloma, lipodystrophy, acute porphyria, polycystic ovary syndrome, etc.; 7. Pregnant or breastfeeding women; 8. Individuals currently participating in other clinical trials; 9. Individuals with unstable clinical status, severe heart failure, uncontrolled arrhythmias, cancer history, life expectancy less than 1 year, or those judged by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-C reduction;Assessment of atherosclerotic plaques; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood biochemical markers;plaque stability and endothelial function-related mediators;other lipid parameters;Inflammatory factors and biomarkers; | — |
Countries
China
Contacts
Public ContactChen Zhenyue
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed