Cholesterol Variability, Trained Immunity
Conditions
Brief summary
Statin treatment significantly reduces the incidence of cardiovascular events. However, cholesterol variability is associated with the risk of adverse events such as mortality, myocardial infarction, and stroke. The previous research found that the inflammatory activity of peripheral blood mononuclear cells in mice fed with intermittent high-fat diet was significantly increased, and the cholesterol variability had an impact on the trained immunity of peripheral blood mononuclear cells, thus aggravating the atherosclerosis in mice. We plan to compare the differences in serum LDL-C levels after intermittent atorvastatin treatment and continuous atorvastatin treatment, and investigate the impact of this difference on the trained immunity of peripheral blood mononuclear cells.
Interventions
DRUGAtorvastatin
Patients are treated with atorvastatin for 2 weeks (40 mg/day), atorvastatin free for 2 weeks, atorvastatin treatment for 2 weeks, atorvastatin free for 2 weeks, a 4-week washout period (no treatment), and atorvastatin treatment for the last 4 weeks.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Voluntarily participate, understand and sign an informed consent form; 2. Age ≥ 18 years old, male or postmenopausal female (defined as amenorrhea over 2 years with relevant clinical characteristics, such as age over 55 years old or menopausal cardiovascular symptoms such as hot flashes, night sweats, palpitations, etc.). Women with hysterectomy and/or bilateral oophorectomy may also be considered for inclusion in the group; 3. Commit to complying with research procedures and cooperate in the implementation of the entire process of research; 4、LDL-c\>3.4mmol/L
Exclusion criteria
1. Previous cardiovascular history; 2. Statins should not be discontinued in high-risk groups for cardiovascular events; 3. Any known organ dysfunction; 4. Intolerance to statins; 5. Pregnant women, lactating women, or women of childbearing age who do not use effective contraception; 6. Participating in other clinical trials; 7. Unable to follow the study procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in LDL-C levels between baseline and atorvastatin treatment cycles | 16 weeks | in the phase of atorvastatin intermittent treatment and continuous treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PBMCs subgroup percentage and activation status | 16 weeks | in the phase of atorvastatin intermittent treatment and continuous treatment |
| PBMCs secreting cytokines | 16 weeks | in the phase of atorvastatin intermittent treatment and continuous treatment |
| Differences in gene expression of PBMCs | 16 weeks | in the phase of atorvastatin intermittent treatment and continuous treatment |
| The levels of hs-CRP, IL-6, IL-18, and sVCAM-1 | 16 weeks | in the phase of atorvastatin intermittent treatment and continuous treatment |
Countries
China
Outcome results
None listed