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The purpose of this study is to gain understanding of mechanisms whereby bariatric surgery modulates pulmonary inflammation and pulmonary microbiome composition and how these changes direct the pathobiology of human obese asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese, early-onset asthmatics | Obese adults (BMI>or= 30) between the ages of 21-60 with an initial asthma diagnosis at <12 years of age |
| |
| Obese, late-onset asthmatics | Obese adults (BMI > or = 30) between the ages of 21-60 with an initial asthma diagnosis at >12 years of age |
| |
| Obese non-asthmatics | Obese adults (BMI > or = 30) between the ages of 21-60 with no asthma diagnosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw | Procedure | 23 ml of blood collected |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in leptin levels | Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery | |
| Change in adiponectin levels | Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery | |
| Change in IL-8 levels | Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery | |
| Change in IL-6 levels | Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery | |
| Change in cystatin-c levels | Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery | |
| Change in IL-17 levels | Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery | |
| Change in IL-1beta levels | Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery | |
| Change in TNF-α levels | Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery | |
| Change in YKL-40 levels | Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery | |
| Change in lung function as measured by forced expiratory volume |
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Inclusion Criteria:
Asthma Subjects
FEV1 within acceptable limits (>45% predicted before and >55% predicted after, bronchodilator administration).
Non-Asthma Control Subjects
Exclusion Criteria:
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Cohort of 15-20 obese, early-onset asthmatic, 15-20 obese, late-onset asthmatic, and 15-20 obese non-asthmatic subjects will be recruited. Subjects in each group will undergo an initial screening visit (V0) to establish the subject groups according to asthma diagnosis, asthma onset age and type of scheduled surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Kunoor Jain-Spangler, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D012143 | Respiratory Physiological Phenomena |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood and sputum
| Sputum collection | Procedure | Induced sputum sample collected |
|
| Pulmonary function test | Procedure | Pulmonary function testing |
|
| Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery |
| Change in lung function as measured by forced vital capacity | Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery |
| Change in lung function as measured by fractional concentration of exhaled nitro oxide | Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery |
| Change in lung function as measured by FEV1/FVC | Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery |
| Change in lung function as measured by forced expiratory flow | Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery |
| 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 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D002943 | Circulatory and Respiratory Physiological Phenomena |