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临床试验/NCT01037465
NCT01037465已完成不适用

ROS Signaling in Endothelial Function

Boston University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Brachial artery flow-mediated dilation

研究概览

简要总结

The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm and thrombosis by producing nitric oxide and other regulatory substances. In patients with atherosclerosis, endothelial function is impaired. Excess production of reactive oxygen species (free radicals) contribute to endothelial dysfunction in atherosclerosis, and some prior studies have shown a beneficial effect of antioxidant treatment on endothelial function in patients with coronary artery disease. On the other hand, reactive oxygen species may be required for normal endothelial function and antioxidant supplements failed to show a benefit in large clinical trials. The effect of antioxidant treatment on endothelial function in healthy subjects is unknown. The present study will test the hypothesis that scavenging reactive species might reduce endothelium-dependent vasodilation in healthy subjects.

The study is a randomized, double-blind, placebo-controlled crossover study. Participants will receive 2.4 grams of oral NAC or similar-appearing placebo during the first visit, and then will cross over to the alternative treatment (NAC or placebo) for the second and final visit. We will examine endothelial function before and after treatment on each visit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

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

入选标准

  • Sex: Male and Female subjects.
  • Age range: 21-65 years old.
  • Disease status: No acute, chronic, or debilitating medical condition or use of prescribed medications.
  • Willingness and ability to provide written informed consent and the ability to understand, to participate and to comply with the study requirements.

排除标准

  • Women with a positive urine beta HCG pregnancy test and lactating women.
  • Blood pressure greater than 140/90 mmHg; serum LDL cholesterol greater than 160 mg/dl; fasting blood sugar greater than 110 mg/dl.
  • History of any cigarette smoking within one year of the study.
  • Clinical history of any acute, chronic, or debilitating medical condition, including liver disease and peptic ulcer disease.
  • Treatment with an investigational new drug within the last 30 days.
  • History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

N-acetylcysteine

Active Comparator

N-acetylcysteine

干预措施: N-acetylcysteine (Drug)

结局指标

主要结局

Brachial artery flow-mediated dilation

时间窗: 4 hours

次要结局

  • Blood markers of antioxidant capacity(4 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Naomi M Hamburg

Principal Investigator

Boston University

研究点 (1)

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