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临床试验/NCT01158573
NCT01158573已完成不适用

Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity

University of Michigan1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2010年7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
117
试验地点
1
主要终点
Urine Cysteinyl Leukotriene Per Creatinine

研究概览

简要总结

The purpose of this study is to examine whether there are higher levels of cysteinyl leukotrienes in obese subjects than in non-obese subjects. Cysteinyl leukotrienes are pro-inflammatory substances that cause asthma by narrowing the airways of the lung. The investigators want to see if subjects with increased fat stores and therefore increased leptin, which is a fat-related protein that regulates leukotrienes, have increased levels of leukotrienes in the blood, lung and urine. The investigators would also like to determine the relationship between cysteinyl leukotrienes and exhaled nitric oxide levels in asthmatics with and without obesity. Nitric oxide is anti-inflammatory and suppresses leukotriene synthesis.

详细描述

This is a cross-sectional observational study to characterize the association between obese asthmatics and the inflammatory mediators cysteinyl leukotrienes. Our hypothesis is that altered adipokine levels in obesity result in augmented cysteinyl leukotriene synthesis that play a significant role in the pathogenesis of asthma in these subjects.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 yr old adults with asthma, non-smoking for at least one year
  • Healthy non-smoking adults, aged 18-65 without asthma
  • Heavy subjects with BMI > 30 kg/m2
  • Subjects with normal weight (BMI between 20-25 kg/m2)
  • Subject not taking anti-leukotriene therapy (Singulair, Accolate, Zyflo)

排除标准

  • No chronic oral steroid use
  • No recent history of infection
  • No recent history of flare of lung disease

结局指标

主要结局

Urine Cysteinyl Leukotriene Per Creatinine

时间窗: sample taken over 5 minutes or less

Urine inflammatory mediators measured from a single urine sample

Ratio U Cys-LT/FeNO

时间窗: sample taken over 5 minutes or less

Responsiveness to leukotriene modifier medication by measuring the urine cysteinyl leukotriene/exhaled nitric oxide ratio

Exhaled Nitric Oxide (FeNO)

时间窗: Observational: Two exhalations within 1 minute

Exhaled breath nitic oxide ppb (averaged values from 2 exhalations per participant)

Plasma Leptin

时间窗: Observational: one time point from a blood draw after more than 6 hours fasting

Measurement of plasma leptin in obese and non obese asthmatics and non-asthmatic subjects from a single blood draw.

次要结局

未报告次要终点

研究者

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

Michael Coffey

Associate Professor Internal Medicine, Pulmonary Division

University of Michigan

研究点 (1)

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