Study of the Effects of Lovaza (Omega 3 Fatty Acids) On Lipoprotein Particles and Their Transcriptional Effects
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in lipoprotein metabolite content and their ability to activate PPAR-alpha in an established cell culture system.
研究概览
简要总结
High levels of triglycerides is a common abnormality found in patients with diabetes and also cardiovascular disease, and may contribute to the risk for both. Omega 3 fatty acids, as found enriched in fish and also in the commercial agent called Lovaza lower triglyceride levels. Prior work from the investigators group demonstrated that an enzyme responsible for the break down of triglycerides - lipoprotein lipase - generates molecules that can activate a specific nuclear receptor known as PPAR-alpha. This study investigates the hypothesis that taking Lovaza shifts the specific fatty acid content of triglyceride containing lipoproteins and increases the ability of those lipoproteins to activate PPAR-alpha.
详细描述
This study will investigate changes in lipid and other metabolic parameters as well as the ability of isolated lipoproteins to activate PPARs in the presence or absence of lipoprotein lipase in a cohort of normal healthy individuals with modest hypertriglyceridemia before and after a course of Lovaza.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Otherwise healthy 21 to 65 year old men and women
- •Triglycerides >150 < 500 mg/dL
排除标准
- •Other lipid lowering medication including fish oil
- •Major illnesses
- •Cardiovascular disease
- •Abnormalities uncovered on screening blood work including undiagnosed diabetes, abnormal liver function tests, triglycerides > 500 mg/dL
- •Indication for immediate statin therapy
- •Pregnancy
- •Contraindication for fish oil use or muscle biopsy
结局指标
主要结局
Changes in lipoprotein metabolite content and their ability to activate PPAR-alpha in an established cell culture system.
时间窗: 3 months
Enrolled subjects will serve as their own controls and will be studied at baseline and after 3 months of Lovaza. The primary endpoint will test changes in lipoproteins as a function of their content and ability to activate PPAR-alpha in standard transfected cell culture systems.
次要结局
- Changes in plasma markers for atherosclerosis(3 months)
- Change in plasma markers of diabetes(3 months)
- Changes in plasma markers of liver function(3 months)
研究者
Jorge Plutzky
Director of Vascular Disease Prevention Program
Brigham and Women's Hospital