A Controlled Dose-Response Human Study to Develop a Signature of Occupational Diesel Exhaust Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Serum proteome in response to DE exposure
研究概览
简要总结
Strong scientific understanding of how emissions from diesel engines impact the lungs could improve policies and regulations protecting workers exposed to diesel exhaust. Accordingly, we are recruiting healthy volunteers who are non-smokers to participate in our study. Volunteers sit in a room for four hours and breathe either clean filtered air or air that contains pollution at various concentrations similar to occupational settings such as bus and ferry terminals where diesel engines are used. A respirologist assesses the volunteer's lung health and clinical samples are taken. We are equipped with advanced molecular biology tools to measure different molecules and compare samples from our volunteer subjects following exposure to clean air or diesel exhaust. Our research aim is to find a simple, clinically relevant strategy that can be used to measure the impact of diesel exhaust on workers' lung health. This knowledge will empower regulators, companies, and ultimately workers to better manage their health risks. Our research aims to provide specific data to help regulators to make informed decisions about the risks of diesel exhaust exposure.
详细描述
- Purpose: Over 100,000 employees in Alberta are inadvertently exposed to diesel exhaust at work because of wide use of diesel engines in vehicles and machines used in road construction, trucking, forestry, oil extraction and mineral mining. Although ambient air monitoring of DE exposure exists in some occupational settings, ambient air monitoring depends heavily on surrogate models and may yield a distorted picture of past exhaust exposure. Thus, a clear exposure limit based on bio-monitoring is needed to adequately protect the workers.
- Objective: Our research aims to establish the relationship between exposure concentration and biological effect as an aid to determination of reference ranges for acceptable exposure.
- Hypotheses and Aims:
Hypothesis 1: Diesel exhaust (DE) inhalation elicits a characteristic protein output, in a dose-dependent manner.
Aim 1. Demonstrate, using a proteomic analysis of serum and urine, a signature that acutely increases in response to a range of occupationally relevant DE concentrations.
Hypothesis 2: DE inhalation increases concentrations of metabolites of polyaromatic hydrocarbons (PAH) in urine, in a dose-dependent manner.
Aim 2. Ascertain the range of PAH metabolites accumulation in urine following acute exposure to a range of occupationally relevant DE concentrations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •19-49 years
- •Non-smokers
- •No physician diagnosed asthma
排除标准
- •Pregnant/breastfeeding
- •Using inhaled corticosteroids
- •Co-existing medical conditions (as assessed by the primary investigator)
- •Taking part in another study that involves taking medications.
- •Abnormal lung function based on screening spirometry
- •Cardiac diagnosis or arrhythmia is discovered during the screening process
结局指标
主要结局
Serum proteome in response to DE exposure
时间窗: 4 hours & 24 hours
Serum from each experimental condition will be analyzed by liquid chromatography-mass spectrometry (LC-MS/MS) to observe any changes between the baseline and listed time points
次要结局
- Urine proteins in response to DE exposure(4 hours & 24 hours)
- Sleep quality(baseline versus 24 hours post-exposure)
- Polycyclic Aromatic Hydrocarbons (PAH) metabolites in response to DE exposure(4 hours & 24 hours)
研究者
Christopher Carlsten
Principal Investigator
University of British Columbia