Atherosclerosis
Conditions
Interventions
Test group:Omega-3 fatty acid
Control group:Blank control
Sponsors
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Participate voluntarily and sign an informed consent form; 2. Age greater than 18 years old at the time of screening, gender is not limited; 3. Diagnosed with type 2 diabetes mellitus [diabetes mellitus: defined as fasting blood glucose =126 mg/dL (=7.0 mmol/L) or non-fasting blood glucose =200 mg/dL (=11.1 mmol/L) or glycosylated hemoglobin =6.5% or on glucose-lowering medications]; and baseline fasting serum triglyceride level =2.3 mmol/L (=200 mg/dL); 4. No clinical cardiovascular events such as acute myocardial infarction, stroke, or history of hemodialysis.
Exclusion criteria
Exclusion criteria: 1. Subjects who have been taking fish oil capsules within 8 weeks prior to enrollment in this study. 2. Subjects who are allergic to the active ingredient, fish, soybeans and corn. 3. Subjects with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) exceeding 3 times the upper limit of the reference value or with significantly elevated creatinine (creatinine > 250 µmol/L). 4. Pregnant or lactating women. 5. Known conditions with increased risk of bleeding, such as recent surgery, gastrointestinal bleeding disorders. 6. Alcohol consumption > 30 g per day for men and > 20 g per day for women. (Alcohol intake [g] = Alcohol volume [ml] * Alcohol content [%] * 0.8). 7. Subjects who have participated in other clinical trials within the previous month. 8. Combination of medications that affect lipid metabolism, such as, for example, glucocorticoids, estrogens, retinoids, cyclosporine, antidepressants, vascular endothelial growth factor inhibitors, aromatase inhibitors, and so on. 9. the combination of diseases affecting lipid metabolism, such as liver disease, nephrotic syndrome, hypothyroidism, systemic lupus erythematosus, glycogen accumulation, myeloma, lipodystrophy, acute porphyria, polycystic ovary syndrome. 10. unstable clinical status, uncontrolled cardiac arrhythmia, history of cancer, life expectancy less than 1 year, and subjects judged by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in triglyceride levels; | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of peripheral atherosclerotic plaques; | — |
Countries
China
Contacts
Public ContactCHEN Zhenyue
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed