Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Coffey, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Pre-assignment weight determined and pulmonary function testing prior to enrollment in observational study
One time point study when mediators were mesaured.
OA Obese Asthma BMI >30
NANO Non asthma non obese
ANO Asthma non obese
NAO Non asthma obese BMI >30
Started July 2010 completed May 2013
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Obese Asthma | Obese Asthma (OA) BMI > 30 Obese Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use. |
| FG001 | Non Asthma, Non-obese | BMI 20-25 Non obese |
| FG002 | Asthma, Non-obese | BMI 20-25 Non obese |
| FG003 | Non Asthma, Obese | BMI .30 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Obese Asthma (OA) | BMI > 30 Obese Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use. |
| BG001 | Non Asthma Non-obese (NANO) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Leptin | Measurement of plasma leptin in obese and non obese asthmatics and non-asthmatic subjects from a single blood draw. | Posted | Mean | Standard Deviation | ng/ml | Observational: one time point from a blood draw after more than 6 hours fasting |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Obese Asthma (OA) | BMI > 30 Obese Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Coffey M.D. | University of Michigan | 734-936-6267 | coffeym@umich.edu |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Subjects will provide 30 cc of blood, a urine sample and we will collect 1-2 ml. of exhaled breath condensate for analysis.
BMI 20-25 Non obese
| BG002 | Asthma Non Obese (ANO) | BMI 20-25 Non obese Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use. |
| BG003 | Non Asthma Obese (NAO) | BMI > 30 Obese |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
BMI 20-25 Non obese Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use. |
| OG003 | Non Asthma Obese (NAO) | BMI > 30 Obese |
|
|
|
| Primary | Exhaled Nitric Oxide (FeNO) | Exhaled breath nitic oxide ppb (averaged values from 2 exhalations per participant) | Posted | Mean | Standard Deviation | parts per billion (ppb) | Observational: Two exhalations within 1 minute |
|
|
|
|
| Primary | Urine Cysteinyl Leukotriene Per Creatinine | Urine inflammatory mediators measured from a single urine sample | Posted | Mean | Standard Deviation | pg/mg creatinine | 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 | Posted | Mean | Standard Deviation | ratio | sample taken over 5 minutes or less |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Non Asthma Non-obese (NANO) | BMI 20-25 Non obese | 0 | 30 | 0 | 30 |
| EG002 | Asthma Non Obese (ANO) | BMI 20-25 Non obese Asthma based on asthma questionnaire, peak flow meter, spirometry, history, physical examination and medication use. | 0 | 29 | 0 | 29 |
| EG003 | Non Asthma Obese (NAO) | BMI > 30 Obese | 0 | 28 | 0 | 28 |
Not provided
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |