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临床试验/NCT01337882
NCT01337882已完成不适用

Inhalation of Dilute Biodiesel Exhaust: Acute Vascular and Endothelial Responses

University of Edinburgh2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Vascular vasomotor and fibrinolytic function

研究概览

简要总结

Exposure to particulate air pollution has been shown to increase cardiovascular mortality and morbidity, and in previous controlled exposure studies has been shown to have acute cardiovascular and respiratory effects. The last decade has seen an unprecedented drive towards finding a bioeconomical and renewable source of fuel in order to reduce our dependence on fossil fuels. Although both biodiesel and bioethanol have emerged as contenders for future fuels, biodiesel remains as the strongest contender within European markets. In 2007 researchers at the EPA released a commentary, which concluded that the assumed correlation between the chemical composition of biodiesel exhaust and a reduction in health effects was only hypothetical. They suggested that there was a clear need for the study of health effects in humans regarding biofuel exhaust. In this project the investigators aim to investigate the cardiovascular, respiratory and inflammatory responses to biofuel exhaust exposure in healthy volunteers.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 20 healthy, non-smoking subjects, age 20-55 year old, both genders.
  • All subjects undergo a general health examination and are required to have:
  • Normal clinical examination Normal EKG Normal routine blood tests Normal lung function

排除标准

  • Cardiovascular disease
  • Diabetes Mellitus
  • Asthma and/or allergy
  • Respiratory infection within 3 weeks of the study
  • Antioxidant- and/or vitamin supplementation within 2 weeks prior to, as well as during the course of the study. (incl vitamin C, Acetylcysteine)
  • Female subjects will take a urinary pregnancy test before each exposure and will be excluded if this is positive.

结局指标

主要结局

Vascular vasomotor and fibrinolytic function

时间窗: 4-6 hours after exposure

Forearm venous occlusion plethysmography to measure forearm blood flow during unilateral intrabrachial infusion of endothelial-dependent (bradykinin and acetylcholine) and -independent (sodium nitroprusside and verapamil) vasodilators. Fibrinolytic function assessed by blood sampling after infusion of bradykinin for tissue plasminogen activator and plasminogen activator inhibitor-1.

次要结局

  • Respiratory function tests(6 hours after exposure)
  • Inflammatory markers(Baseline and up to 24 hours after exposure)
  • Central arterial stiffness(Baseline and post exposure)

研究者

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

Jeremy Langrish

Clinical Lecturer and Specialty Registrar in Cardiology

University of Edinburgh

研究点 (2)

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