Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity

Completed

• Conditions: Asthma; Obesity

• Registration Number: NCT01158573
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-07
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-08
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2015-12-14
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-14
• Last Update Submitted: 2017-06-14
• Results First Posted: 2018-01-24
• Last Update Posted: 2018-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

• 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)

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Urine Cysteinyl Leukotriene Per Creatinine	sample taken over 5 minutes or less	Urine inflammatory mediators measured from a single urine sample
Ratio U Cys-LT/FeNO	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)	Observational: Two exhalations within 1 minute	Exhaled breath nitic oxide ppb (averaged values from 2 exhalations per participant)
Plasma Leptin	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States