Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity

June 14, 2017 updated by: Michael Coffey, University of Michigan
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy non-asthmatic obese adults
Healthy non-asthmatic non-obese adults
Asthmatic obese adults
Asthmatic non-obese adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Leptin
Time Frame: 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.
Observational: one time point from a blood draw after more than 6 hours fasting
Exhaled Nitric Oxide (FeNO)
Time Frame: Observational: Two exhalations within 1 minute
Exhaled breath nitic oxide ppb (averaged values from 2 exhalations per participant)
Observational: Two exhalations within 1 minute
Urine Cysteinyl Leukotriene Per Creatinine
Time Frame: sample taken over 5 minutes or less
Urine inflammatory mediators measured from a single urine sample
sample taken over 5 minutes or less
Ratio U Cys-LT/FeNO
Time Frame: sample taken over 5 minutes or less
Responsiveness to leukotriene modifier medication by measuring the urine cysteinyl leukotriene/exhaled nitric oxide ratio
sample taken over 5 minutes or less

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Michael Coffey, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 7, 2010

First Submitted That Met QC Criteria

July 7, 2010

First Posted (Estimate)

July 8, 2010

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

June 14, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36879

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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