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Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by University of Michigan.
Recruitment status was:  Recruiting
Merck Sharp & Dohme Corp.
Information provided by:
University of Michigan Identifier:
First received: July 7, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
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.

Asthma Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity

Further study details as provided by University of Michigan:

Biospecimen Retention:   Samples Without DNA
Subjects will provide 30 cc of blood, a urine sample and we will collect 1-2 ml. of exhaled breath condensate for analysis.

Estimated Enrollment: 160
Study Start Date: July 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Healthy non-asthmatic obese adults
Healthy non-asthmatic obese adults
Healthy non-asthmatic non-obese adults
Healthy non-asthmatic non-obese adults
Asthmatic obese adults
Asthmatic obese adults
Asthmatic non-obese adults
Asthmatic non-obese adults

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
UM Housing Residents/Student Dorms UM Human Research Recruiting Registry (e.g., ENGAGE - Department or unit-specific research recruiting registry (provide UM IRB project number below) Other UM subject pools (describe below) Patients or their medical records from the UM Health System or any other UM health care provider (e.g., School of Dentistry, University Health Service, University Center for Language and Literacy)

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01158573

United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Barbara A Torretti, BA    734-936-9875   
Principal Investigator: Michael Coffey, MD         
Sponsors and Collaborators
University of Michigan
Merck Sharp & Dohme Corp.
Principal Investigator: Michael Coffey, MD University of Michigan
  More Information

Responsible Party: Michael Coffey, MD/Principal Investigator, University of Michigan Health System, Department of Internal Medicine Identifier: NCT01158573     History of Changes
Other Study ID Numbers: 36879
Study First Received: July 7, 2010
Last Updated: July 7, 2010

Keywords provided by University of Michigan:

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017