Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity

NCT01158573 | Completed Results DMC

• 1 other identifier: 36879
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Obesity

Keywords

Asthma; Obesity

Outcome Measures

Primary Outcomes (4)

• 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

• Exhaled Nitric Oxide (FeNO)

  Exhaled breath nitic oxide ppb (averaged values from 2 exhalations per participant)

  Observational: Two exhalations within 1 minute

• Urine Cysteinyl Leukotriene Per Creatinine

  Urine inflammatory mediators measured from a single urine sample

  sample taken over 5 minutes or less

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• No chronic oral steroid use
• No recent history of infection
• No recent history of flare of lung disease

Sponsors & Collaborators

• University of Michigan: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

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.

MeSH Terms

Conditions

Asthma; Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Michael Coffey M.D.
• Organization: University of Michigan

coffeym@umich.edu

734-936-6267

Study Officials

• Michael Coffey, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Internal Medicine, Pulmonary Division

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 8, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 24, 2018
• Results First Posted: January 24, 2018

Record last verified: 2017-06

Locations

US (1)