We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01158573
Recruitment Status : Completed
First Posted : July 8, 2010
Results First Posted : January 24, 2018
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Michael Coffey, University of Michigan

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.

Condition or disease
Asthma Obesity

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
Actual Enrollment : 117 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity
Study Start Date : July 2010
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Group/Cohort
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



Primary Outcome Measures :
  1. 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.

  2. Exhaled Nitric Oxide (FeNO) [ Time Frame: Observational: Two exhalations within 1 minute ]
    Exhaled breath nitic oxide ppb (averaged values from 2 exhalations per participant)

  3. Urine Cysteinyl Leukotriene Per Creatinine [ Time Frame: sample taken over 5 minutes or less ]
    Urine inflammatory mediators measured from a single urine sample

  4. 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


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.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 - 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158573


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Michael Coffey, MD University of Michigan

Responsible Party: Michael Coffey, Associate Professor Internal Medicine, Pulmonary Division, University of Michigan
ClinicalTrials.gov Identifier: NCT01158573     History of Changes
Other Study ID Numbers: 36879
First Posted: July 8, 2010    Key Record Dates
Results First Posted: January 24, 2018
Last Update Posted: January 24, 2018
Last Verified: June 2017

Keywords provided by Michael Coffey, University of Michigan:
Asthma
Obesity

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