Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity

Obesity Clinical Trial

Official title:

Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158573
• Other study ID #: 36879
• Status: Completed
• Phase: N/A
• First received: July 7, 2010
• Last updated: June 14, 2017
• Start date: July 2010
• Est. completion date: May 2013

Study information

• Verified date: June 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Obesity

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Leptin	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
Primary	Exhaled Nitric Oxide (FeNO)	Exhaled breath nitic oxide ppb (averaged values from 2 exhalations per participant)	Observational: Two exhalations within 1 minute
Primary	Urine Cysteinyl Leukotriene Per Creatinine	Urine inflammatory mediators measured from a single urine sample	sample taken over 5 minutes or less
Primary	Ratio U Cys-LT/FeNO	Responsiveness to leukotriene modifier medication by measuring the urine cysteinyl leukotriene/exhaled nitric oxide ratio	sample taken over 5 minutes or less