Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma

Study Overview
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Brief Summary
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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.

Official Title
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Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma

Conditions
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Asthma, Obesity

Intervention / Treatment
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* Procedure: Blood draw
* Procedure: Sputum collection
* Procedure: Pulmonary function test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asthma Subjects Outpatient adults of either sex 21-60 years of age with an initial asthma diagnosis at < 12 years of age (early-onset) or >12 years of age (late-onset), as defined by the NHLBI NAEPP guidelines (17). Subjects with obesity (BMI ≥ 30 kg/m2). Physician diagnosis of asthma. Eligible and scheduled for bariatric surgery (Roux-en-Y gastric bypass, sleeve gastrectomy or duodenal switch) and receiving care within the Duke Health System. FEV1 within acceptable limits (>45% predicted before and >55% predicted after, bronchodilator administration). Relatively healthy subjects able to undergo sputum induction without complications. Willing and able to give informed consent and adhere to visit/protocol schedules. Read and write in English. Non-Asthma Control Subjects Outpatient adults of either sex 21-60 years of age. Subjects with obesity (BMI ≥ 30). Eligible and scheduled for bariatric surgery (Roux-en-Y gastric bypass, sleeve gastrectomy or duodenal switch) at Duke Regional Hospital and receiving care at the Duke Metabolic and -Weight Loss Surgery Center. Normal lung function. No clinical history of atopy. No significant medical or psychological issues. Healthy subjects able to undergo sputum induction without complications. Willing and able to give informed consent and adhere to visit/protocol schedules. Read and write in English. Exclusion Criteria: Children < 21 years of age. Inpatient status. Ineligibility or not scheduled for bariatric surgery at the Duke Metabolic and Weight Loss Surgery Center. FEV1 is less than 45% predicted before, or less than 55% predicted after, bronchodilator administration. Upper or lower respiratory tract infection within one month of the study. Use of systemic corticosteroids within four weeks of study. Smoking (tobacco, e-cigarette, vaping or inhaled drugs) history > 5 pack years or smoking or vaping within the previous six months. Significant non-asthma pulmonary disease (stable obstructive sleep apnea is not excluded). An ED visit or inpatient admission for a primary respiratory diagnosis within 60 days of enrollment. Poorly controlled concomitant conditions that pose additional procedure risk as determined by the investigator. All patients on anticoagulants. Uncontrolled sleep apnea.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese, early-onset asthmatics<br>Obese adults (BMI>or= 30) between the ages of 21-60 with an initial asthma diagnosis at <12 years of age | Procedure: Blood draw<br>* 23 ml of blood collected<br>Procedure: Sputum collection<br>* Induced sputum sample collected<br>Procedure: Pulmonary function test<br>* Pulmonary function testing<br>|
| Obese, late-onset asthmatics<br>Obese adults (BMI > or = 30) between the ages of 21-60 with an initial asthma diagnosis at >12 years of age | Procedure: Blood draw<br>* 23 ml of blood collected<br>Procedure: Sputum collection<br>* Induced sputum sample collected<br>Procedure: Pulmonary function test<br>* Pulmonary function testing<br>|
| Obese non-asthmatics<br>Obese adults (BMI > or = 30) between the ages of 21-60 with no asthma diagnosis | Procedure: Blood draw<br>* 23 ml of blood collected<br>Procedure: Sputum collection<br>* Induced sputum sample collected<br>Procedure: Pulmonary function test<br>* Pulmonary function testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  | 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 |