Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01158573
First received: July 7, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition
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

Resource links provided by NLM:


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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

UM Housing Residents/Student Dorms UM Human Research Recruiting Registry (e.g., ENGAGE - http://www.med.umich.edu/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)

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158573

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

No publications provided

Responsible Party: Michael Coffey, MD/Principal Investigator, University of Michigan Health System, Department of Internal Medicine
ClinicalTrials.gov Identifier: NCT01158573     History of Changes
Other Study ID Numbers: 36879
Study First Received: July 7, 2010
Last Updated: July 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Asthma
Obesity

Additional relevant MeSH terms:
Asthma
Obesity
Body Weight
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Nutrition Disorders
Overnutrition
Overweight
Respiratory Hypersensitivity
Respiratory Tract Diseases
Signs and Symptoms
Cysteinyl-leukotriene
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014