ATORVASTATIN ON PLASMA CHOLINE CONCENTRATION IN SUBJECTS WITH AND WITHOUT THE ME

阿托伐他汀对有和没有 ME 受试者血浆胆碱浓度的影响

• 批准号: 7716914
• 负责人: DAVID Robert CLEMMONS
• 金额: $ 0.19万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-02 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716914
• 关键词: Alleles; Blood specimen; Choline; Collection; Computer Retrieval of Information on Scientific Projects Database; Daily; Diet; Dose; Fasting; Funding; Genes; Genetic Polymorphism; Grant; Human; Institution; Interview; Measurement; Methods; Methylenetetrahydrofolate Dehydrogenase (NADP+); Methylenetetrahydrofolate reductase (NADPH); Myopathy; Participant; Plasma; Procedures; Purpose; Research; Research Personnel; Resources; Risk Factors; Serum; Signs and Symptoms; Source; United States National Institutes of Health; Week; aged; atorvastatin; base; demographics; feeding; male

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. Purpose: This study is to determine the effect of atorvastatin on plasma choline concentration in humans with and without the G1958A allele of the methylenetetrahydrofolate reductase 1 (MTHFD1) gene. Participants: The study will be conducted on healthy males aged 18-75 without known risk factors for statin intolerance. Procedures (methods): 60 subjects will be screened for the G1958A polymorphism of the gene for methylenetetrahydrofolate dehydrogenase 1 (MTHFD1). 25 subjects will be chosen based on presence or absence of the polymorphism. Efforts will be made to reflect local demographics. Subjects will be fed a diet with a consistent, but not restricted, choline content for five weeks. In the middle three weeks of the study (weeks two through four), subjects will be administered atorvastatin daily at an escalating dose: 10 mg daily for one week, 20 mg daily for one week, and 40mg daily for one week. Subjects will have weekly exams and interviews to screen for signs and symptoms of myopathy; and weekly fasting collection of blood samples for measurement of serum ALT, serum CK, and plasma choline.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 目的： 本研究旨在确定阿托伐他汀对服用和不服用阿托伐他汀的人体血浆胆碱浓度的影响。 亚甲基四氢叶酸还原酶 1 (MTHFD1) 基因的 G1958A 等位基因。 参加者： 该研究将针对 18-75 岁、没有已知的他汀类药物不耐受危险因素的健康男性进行。 程序（方法）： 将对 60 名受试者进行亚甲基四氢叶酸脱氢酶 1 (MTHFD1) 基因 G1958A 多态性筛查。将根据多态性的存在或不存在来选择25名受试者。 将努力反映当地的人口统计数据。受试者将被喂食胆碱含量一致但不受限的饮食五周。在研究的中间三周（第二周至第四周），受试者每天服用阿托伐他汀，剂量逐渐增加：每天 10 毫克，持续一周；每天 20 毫克，持续一周；以及每天 40 毫克，持续一周。受试者将每周进行一次检查和访谈，以筛查肌病的体征和症状；每周空腹采集血样以测量血清 ALT、血清 CK 和血浆胆碱。