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There are two aims for this study. The purpose of this study is to determine the effects of body weight and hormones on airway fibrosis (scarring) and lung function in obese & lean asthma subjects compared to obese & lean non-asthma subjects (Aim 1). And in obese subjects with asthma undergoing bariatric surgery compared to obese non-asthma subjects undergoing bariatric surgery (Aim 2).
Main Study
Specific Aim 1: Determine the effects of signaling on airway fibrosis and lung function in obese asthma and non-asthma patients. The investigators will:
•Perform assessments to determine if obese, early-onset asthma patients are more susceptible to airway fibrosis and remodeling than lean, early-onset asthma patients and obese and lean, non-asthma patients.◦
Specific Aim 2: Investigate the mechanism by which bariatric surgery slows the progression of airway fibrosis in obese human asthma. The investigators will:
•Perform assessments to determine if airway fibrosis in obese, early-onset asthma and obese non-asthma patients improves following bariatric surgery and weight loss◦
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese asthmatic & lean asthmatic | men and women with asthma and either obese or lean BMI | ||
| Obese non-asthmatic & lean non-asthmatic | men and women without asthma and either obese or lean BMI | ||
| Asthmatic undergoing bariatric surgery | Obese asthmatic men and women undergoing bariatric surgery | ||
| Non-asthmatic undergoing bariatric surgery | Obese men and women undergoing bariatric surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Airway fibrosis | Obese asthmatics compared to lean asthmatics, obese non-asthmatics and lean non-asthmatics: A univariate linear model will be constructed to measure the effect of leptin or GLP-1 (glucagon-like peptide-1) on airway fibrosis, as measured by the ratio of Masson's trichrome-stained area to non-stained area in the sub-mucosal region of airway biopsy tissue. | Visit 2 (14 days) |
| Change in airway fibrosis | Asthmatics undergoing bariatric surgery and non-asthmatics undergoing bariatric surgery: Each patient will serve as its own control in comparing pre- and post-operative airway fibrosis. A univariate linear model will be constructed to measure the effect of bariatric surgery on airway fibrosis, as measured by the ratio of Masson's trichrome-stained area to non-stained area in the sub-mucosal region of airway biopsy tissue. | Visit 2 (14 days), Visit 4 (1 year + 14 days) |
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Inclusion Criteria:
Obese asthmatic & lean asthmatic
Obese non-asthmatic & Lean non-asthmatic
Asthmatic undergoing bariatric surgery
Non-Asthmatic undergoing bariatric surgery
Exclusion Criteria:
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Subjects will be recruited from the clinics of the Duke Asthma, Allergy and Airway Center, the Duke Metabolic and Weight Loss Surgery Center, the Duke Raleigh Weight Loss Surgery Center, and the Duke Diet and Fitness Center. Healthy controls without lung disease will be recruited from the surrounding area.
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| Name | Affiliation | Role |
|---|---|---|
| Loretta Que, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Metabolic and Weight Loss Surgery Center | Durham | North Carolina | 27704 | United States | ||
| Duke Asthma Allergy and Airway Center |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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blood plasma, bronchoscopy with endobronchial biopsy and brushings, bronchoalveolar lavage, RNA
| Durham |
| North Carolina |
| 27705 |
| United States |
| 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 |