VASCULAR & LIPID EFFECTS OF OMACOR IN SUBJECTS WITH MODERATELY ELEVATED TRIGLYCE

血管

• 批准号: 7951329
• 负责人: SHELIA G WEST
• 金额: $ 9.61万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951329
• 关键词: Anti-Inflammatory Agents; Anti-inflammatory; Blood Vessels; Cardiovascular system; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Crossover Design; Docosahexaenoic Acids; Dose; Double-Blind Method; Dyslipidemias; Eicosapentaenoic Acid; Epidemiologic Studies; Erythrocytes; Evaluation; FDA approved; Fishes; Funding; Grant; Health; Hypertriglyceridemia; Incidence; Inflammation; Institution; Intake; Intervention; Lipids; Measures; Mediating; Medical; Omacor; Omega-3 Fatty Acids; Patients; Pharmaceutical Preparations; Physiological; Placebo Control; Placebos; Play; Randomized; Recommendation; Research; Research Personnel; Resources; Role; Source; Stress; Triglycerides; United States National Institutes of Health; base; heart disease risk; improved; indexing; inflammatory marker; mortality; response; treatment duration

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are abundant in fish and have been found to play an important role in protecting cardiovascular health although the complete mechanisms of action are still poorly understood. Omega-3 fatty acids are effective in lowering triglycerides in a dose-dependent manner and have been shown to have anti-inflammatory and vascular-health-promoting effects in some studies. Omacor is an FDA-approved drug that is a concentrated form of EPA and DHA and is used to lower triglycerides in patients with very high triglycerides (> 500 mg/dL). In this study we will give 1 g and 4 g doses of Omacor to 25 subjects with moderate hypertriglyceridemia (150-500 mg/dL) because they are at elevated risk for heart disease but currently do not receive medical treatment for this form of dyslipidemia. We are using a randomized, placebo-controlled, double-blind, crossover design with three 8-week treatment periods (1 g, 4 g, and placebo) and 6-week washout periods between treatments. Our primary endpoints are measures of physiologic responses to stress and flow-mediated dilation (a measure of endothelial health). Both measures are thought to predict incidence of cardiovascular mortality. We will also measure erythrocyte omega-3 fatty acid concentration (the omega-3 index) and markers of inflammation, and perform a complete lipid panel. We hypothesize that the 4 g dose will lower triglycerides 20-35%, improve stress reactivity and flow-mediated dilation, and possibly result in decreased inflammation. We feel that it is important to study the 1 g dose to provide an evaluation of the upper level of current dietary recommendations; however we cannot predict its effects on our vascular endpoints. Little research has used this more moderate dose even though it is the current recommended daily intake for cardiovascular health based on large intervention and epidemiological studies.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 Omega-3脂肪酸Eicosapentaenoic（EPA）和Docosahecahecahecaenoic acrac（DHA）在鱼类中含量丰富，并且发现完全了解了作用的完整机制，在保护心血管健康方面起着重要作用。 omega-3脂肪酸可有效地以剂量依赖性的方式降低甘油三酸酯，并已证明在某些研究中具有抗炎和血管疾病的促进作用。 Omacor是一种经FDA批准的药物，是EPA和DHA的浓缩形式，用于降低甘油三酸酯非常高的患者（> 500 mg/dl）的甘油三酸酯。在这项研究中，我们将为25名中度高甘油三酯血症（150-500 mg/dL）的受试者提供1 g和4 g剂量的omacor，因为它们患有心脏病的风险升高，但目前尚未接受这种形式的患者血脂血症。 我们使用的是一个随机的，安慰剂对照的双盲，跨界设计，有三个8周的治疗期（1 g，4 g和安慰剂）和治疗之间的6周冲洗周期。 我们的主要终点是对压力和流动介导的扩张的生理反应的度量（内皮健康的量度）。两种措施都被认为可以预测心血管死亡率的发生率。 我们还将测量红细胞omega-3脂肪酸浓度（欧米茄-3指数）和炎症标记，并执行完整的脂质面板。 我们假设4 g剂量将降低甘油三酸酯20-35％，改善应力反应性和流动介导的扩张，并可能导致炎症减少。 我们认为，研究1 g剂量的评估是对当前饮食建议的上层评估很重要的；但是，我们无法预测其对我们的血管终点的影响。 尽管目前，基于大型干预和流行病学研究，但很少的研究使用了这种更为中等的剂量。