Pharmaco-metabolomic Effects of Statins: METASTATINE
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Rate of trimethylamine N-oxide trimethylamine oxide in blood, measured post-prandially at week-6 in atorvastatin arm and placebo arm.
研究概览
简要总结
Statins are effective in cardio-vascular prevention by lowering LDL-Cholesterol levels but also through other mechanisms poorly understood. Our hypothesis is that some of these effects are mediated by microbiota alteration, leading to diminution of expression of microbiota derived pro-atherogenic metabolites.
详细描述
The aim of this prospective double blind placebo-controlled study is to evaluate the acute effects of statins on microbiota and its derived metabolites at 2 and 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Placebo manufactured as the treatment. Packaging identical.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with cardiovascular risk requiring statins in primary prevention
- •Contraception for women of childbearing age
排除标准
- •Previous antibiotics, proton pomp inhibitors, statins or other hypolipidemic drugs intake in the previous three months
- •Renal insufficiency with creatinine clearance <40ml/min
- •Contra-indication to statins
- •Previously known conditions affecting muscles, or digestive system
- •Requirement of statins in secondary prevention
研究组 & 干预措施
ATORVASTATIN
Atorvastatin 40mg caps: one daily. 3 patient visits: inclusion / week 2 / week 6. At each visit, blood sampling, stool sampling, ECG, to evaluate the pharmaco-metabolomic effects of the Statine
干预措施: Atorvastatin 40mg Tablet (Drug)
PLACEBO
Placebo caps: one daily. 3 patient visits: inclusion / week 2 / week 6. At each visit, blood sampling, stool sampling, ECG to compare the pharmaco-metabolomic effects of the Statine between atorvastatin arm and placebo arm
干预措施: Placebo comparator (Drug)
结局指标
主要结局
Rate of trimethylamine N-oxide trimethylamine oxide in blood, measured post-prandially at week-6 in atorvastatin arm and placebo arm.
时间窗: Week-6
The main objective of the study is to measure the direct effect of Hydroxy-methyl-glutaryl-coenzyme A reductase inhibitors (Atorvastatin) on the production of atherogenic metabolites derived from intestinal microbiota
次要结局
- Comparison between W0, W2 and W6 after initiation of atorvastatin vs placebo of circulating metabolomic profile (pre- and postprandial)(Week 2 and Week 6)
- Rate of trimethylamine N-oxide trimethylamine oxide in blood, measured post-prandially at week-2 in atorvastatin arm and placebo arm.(week-2)
- Comparison between W0, W2 and W6 after initiation of atorvastatin vs placebo of the microbiome(Week 2 and Week 6)
- Rate of trimethylamine N-oxide trimethylamine oxide in blood, measured pre and post-prandially at week-2 and week-6 in atorvastatin arm.(Week-2 and week-6)