Clinical trial NCT01158573: Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity
Official title: Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Obesity
Keywords: Asthma
Obesity
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-07-08
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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)

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.

Eligibility 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

Primary outcomes:
measure: Plasma Leptin
timeFrame: Observational: one time point from a blood draw after more than 6 hours fasting
measure: Exhaled Nitric Oxide (FeNO)
timeFrame: Observational: Two exhalations within 1 minute
measure: Urine Cysteinyl Leukotriene Per Creatinine
timeFrame: sample taken over 5 minutes or less
measure: Ratio U Cys-LT/FeNO
timeFrame: sample taken over 5 minutes or less
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Michael Coffey, MD
role: PRINCIPAL_INVESTIGATOR
References: