Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma
NCT ID: NCT04247971
Last Updated: 2023-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
16 participants
OBSERVATIONAL
2021-04-30
2023-02-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Blood draw
23 ml of blood collected
Sputum collection
Induced sputum sample collected
Pulmonary function test
Pulmonary function testing
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
Blood draw
23 ml of blood collected
Sputum collection
Induced sputum sample collected
Pulmonary function test
Pulmonary function testing
Obese non-asthmatics
Obese adults (BMI \> or = 30) between the ages of 21-60 with no asthma diagnosis
Blood draw
23 ml of blood collected
Sputum collection
Induced sputum sample collected
Pulmonary function test
Pulmonary function testing
Interventions
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Blood draw
23 ml of blood collected
Sputum collection
Induced sputum sample collected
Pulmonary function test
Pulmonary function testing
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
60 Years
ALL
Yes
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Kunoor Jain-Spangler, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00104326
Identifier Type: -
Identifier Source: org_study_id
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