跳至主要内容
临床试验/NCT01508637
NCT01508637Unknown不适用

Effect of Diesel Exhaust Exposures on Vascular Function in Humans: The Role of Sympathetic Activation

University of Washington1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
24
试验地点
1
主要终点
Systolic Blood Pressure

研究概览

简要总结

Double-blind, sham- and placebo-controlled randomized study of effects of freshly-generated diluted diesel exhaust inhalation on vascular function. To examine role of adrenergic system a trial of alpha-blocker terazosin is also used. Each participant completes four study sessions, separated by at least three weeks: 1) Diesel exhaust inhalation (DE, controlled at 300 micrograms/cubic meter for two hours) and terazosin (2 mg prior to inhalation exposure); 2) DE plus placebo (matched for terazosin); 3) filtered air plus terazosin; and 4) filter air plus placebo. The investigators assess outcomes of blood pressure, forearm brachial artery ultrasound, and plasma measures of endothelial activation. The investigators hypothesize that DE exposure will be associated with increased blood pressure, decreased brachial artery diameter, and increased circulating endothelins, and that these effects will be attenuated by terazosin administration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy without chronic illness
  • Body Mass Index 18.5 - 26.0
  • tolerates 2 mg terazosin dose without unacceptable symptoms
  • able to return for four exposure sessions

排除标准

  • any chronic disease
  • tobacco user
  • elevated cholesterol
  • hypertension
  • any chronic cardiovascular or pulmonary disease
  • pregnancy or unwillingness to use effective contraception, if female

研究组 & 干预措施

Diesel Exhaust + placebo

Experimental

干预措施: placebo (Drug)

Diesel Exhaust + Terazosin

Experimental

干预措施: Diesel Exhaust (Other)

Diesel Exhaust + Terazosin

Experimental

干预措施: Terazosin (Drug)

Diesel Exhaust + placebo

Experimental

干预措施: Diesel Exhaust (Other)

Filtered Air + terazosin

Sham Comparator

干预措施: Filtered Air (Other)

Filtered Air + terazosin

Sham Comparator

干预措施: Terazosin (Drug)

Filtered air + placebo

Sham Comparator

干预措施: Filtered Air (Other)

Filtered air + placebo

Sham Comparator

干预措施: placebo (Drug)

结局指标

主要结局

Systolic Blood Pressure

时间窗: 30-90 minutes after exposure initiation

次要结局

  • Brachial artery diameter(Assessed 30 minutes prior to exposure and 30 minutes post-exposure)

研究者

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

Joel Daniel Kaufman

Professor

University of Washington

研究点 (1)

Loading locations...

相似试验