A Randomized, Placebo Controlled Clinical Trial to Evaluate the Effects of Simvastatin Treatment on Measurements of Lipidomic Biomarkers in Men With Dyslipidemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Arachidonic Acid Level After 2 Weeks of Treatment
研究概览
简要总结
The purpose of this study was to provide human lipidomics standards with simvastatin treatment that were to be used for comparison with similar preclinical studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participant is a Caucasian (including Hispanic) male
- •Participant has a maximum waist size of 40 inches
- •Participant does not currently use any lipid-altering medications
- •Participant is in good health other than the diagnosis of dyslipidemia
排除标准
- •Participant has had stomach ulcers within the last 3 months
- •Participant has had a heart attack in the last 6 months or has angina
- •Participant has chronic heart failure
- •Participant has a history of stroke, seizures, or major neurological disorder
- •Participant has a history of cancer
- •Participant has a gastrointestinal condition that affects bowel movements
- •Participant has type 1 or 2 diabetes
研究组 & 干预措施
Simvastatin 40 mg first, then placebo
Simvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks
干预措施: Simvastatin (Drug)
Simvastatin 40 mg first, then placebo
Simvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks
干预措施: Placebo (Drug)
Placebo first, then simvastatin 40 mg once daily
Placebo for 2 weeks followed by simvastatin 40 mg once daily for 2 weeks
干预措施: Simvastatin (Drug)
Placebo first, then simvastatin 40 mg once daily
Placebo for 2 weeks followed by simvastatin 40 mg once daily for 2 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Arachidonic Acid Level After 2 Weeks of Treatment
时间窗: 2 weeks
Arachidonic acid level (20:4n6) in the cholesterol ester lipid class. The mean reported was an adjusted mean, which was obtained from running a 2-period crossover model that had fixed treatment and period terms and a random participant term.
次要结局
- Blood Linoleic Acid Levels(2 weeks)
- Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo(2 weeks)
- Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level(2 weeks)
- Fasting Blood Lipidomic Levels After 2 Weeks of Treatment(2 weeks)