A Clinical Observational Trail on Atorvastatin Regulates Intestinal Flora and Metabolomics.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of flora
研究概览
简要总结
Recent studies suggest that gut microbiome, the microbial community in the intestine, may directly and indirectly influence the progression of atherosclerosis. The imbalance of gut microbiome may directly promote the formation of atherosclerotic plaques by promoting the inflammatory reaction and oxidative stress affecting vascular endothelial function and increasing platelet activity. Meanwhile, it can indirectly increase the risk of atherosclerosis by enhance insulin resistance, reducing the production of bile acids and raising serum LDL-C and angiotensin levels. As shown in these researches, gut microbiome, acting as a bridge between metabolism, energy and inflammatory responses, may play an important role in cardiovascular diseases, and we believe that the interaction between microbiome and host should be considered in the ASCVD study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years;
- •Statin indications such as lipid metabolism disorders, diabetes, elevated CRP, atherosclerosis; stratification according to ASCVD risk; indications for statin treatment
- •Not using statins and other lipid-lowering drugs for at least 6 months before enrollment;
- •Agree to receive research treatment plan;
- •Voluntarily sign the informed consent.
排除标准
- •People with active gastrointestinal bleeding or have a clear history of gastrointestinal ulcers or bleeding in the past 2 years;
- •Severe renal insufficiency (eGFR <30ml / min / 1.73m2);
- •Active hepatitis, liver cirrhosis, or ALT increase more than 3 times;
- •Those with severe hypertension (> 180 / 110mmHg) and currently have no control;
- •Hemoglobin <100g / L;
- •Platelet count <100 × 109 cells / L;
- •Suffering from a known serious progressive disease (such as a malignant tumor) or a disease that causes the patient to fail extremely, the estimated survival time is <12 months;
- •pregnant or intending to become pregnant;
- •Any situation that may interfere with the research process, such as dementia, paralysis, alcoholism, etc .;
- •Expected to undergo surgery within 1 year;
- •Patients participating in other ongoing clinical studies.
研究组 & 干预措施
Atorvastatin regulates intestinal flora
干预措施: Atorvastatin 20 Mg Oral Tablet (Drug)
结局指标
主要结局
Number of flora
时间窗: 4 months
次要结局
未报告次要终点