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NCT Number: NCT01158573

Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity

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.

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Key information

Conditions

Asthma Body Weight Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 8, 2010
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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