Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity

NCT ID: NCT01158573

Last Updated: 2018-01-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Asthma Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy non-asthmatic obese adults

Healthy non-asthmatic obese adults

No interventions assigned to this group

Healthy non-asthmatic non-obese adults

Healthy non-asthmatic non-obese adults

No interventions assigned to this group

Asthmatic obese adults

Asthmatic obese adults

No interventions assigned to this group

Asthmatic non-obese adults

Asthmatic non-obese adults

No interventions assigned to this group

Eligibility Criteria

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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)

Exclusion Criteria

* No chronic oral steroid use
* No recent history of infection
* No recent history of flare of lung disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Michael Coffey

Associate Professor Internal Medicine, Pulmonary Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Coffey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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36879

Identifier Type: -

Identifier Source: org_study_id

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