Contributing Factors in the Pathobiology of Airway Remodeling in Obesity
NCT ID: NCT03115632
Last Updated: 2023-09-22
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
31 participants
OBSERVATIONAL
2018-04-09
2023-06-27
Brief Summary
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Detailed Description
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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◦
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Obese asthmatic & lean asthmatic
men and women with asthma and either obese or lean BMI
No interventions assigned to this group
Obese non-asthmatic & lean non-asthmatic
men and women without asthma and either obese or lean BMI
No interventions assigned to this group
Asthmatic undergoing bariatric surgery
Obese asthmatic men and women undergoing bariatric surgery
No interventions assigned to this group
Non-asthmatic undergoing bariatric surgery
Obese men and women undergoing bariatric surgery
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Outpatient adults of either sex 18-60 years of age with an initial asthma diagnosis at \< 12 years of age, as defined by the NHLBI National Asthma Education and Prevention Program (NAEPP) guidelines.
2. Lean subjects with body mass index (BMI) ≥ 20 kg/m2 and \< 30 kg/m2 or obese subjects with BMI ≥ 30 and ≤ 55 kg/m2
3. Physician diagnosis of asthma
4. Forced expiratory volume at one second (FEV1) within acceptable limits (\>45% predicted before and \>55% predicted after, bronchodilator administration).
5. Negative pregnancy test in women of childbearing potential (confirmed during screening).
6. Relatively healthy subjects able to undergo bronchoscopy without complications.
7. Willing and able to give informed consent and adhere to visit/protocol schedules.
8. Read and write in English.
Obese non-asthmatic \& Lean non-asthmatic
1. Outpatient adults of either sex 18-60 years of age.
2. Lean subjects with body mass index (BMI) ≥ 20 kg/m2 and \< 30 kg/m2 or obese subjects with BMI ≥ 30 and ≤ 55 kg/m2
3. Negative pregnancy test in women of childbearing potential (confirmed during screening).
4. Normal lung function.
5. No clinical history of atopy.
6. No significant medical or psychological issues.
7. Healthy subjects able to undergo bronchoscopy without complications.
8. Willing and able to give informed consent and adhere to visit/protocol schedules.
9. Read and write in English.
Asthmatic undergoing bariatric surgery
1. Outpatient adults of either sex 18-60 years of age with an initial asthma diagnosis at \< 12 years of age, as defined by the NHLBI NAEPP guidelines.
2. Physician diagnosis of asthma
3. FEV1 within acceptable limits (\>45% predicted before and \>55% predicted after, bronchodilator administration).
4. Morbidly obese subjects undergoing bariatric surgery and receiving care at the Duke Metabolic and Weight Loss Surgery Center.
5. Negative pregnancy test in women of childbearing potential (confirmed during screening).
6. Relatively healthy subjects able to undergo bronchoscopy without complications.
7. Willing and able to give informed consent and adhere to visit/protocol schedules.
8. Read and write in English.
Non-Asthmatic undergoing bariatric surgery
1. Outpatient adults of either sex 18-60 years of age.
2. Morbidly obese subjects undergoing bariatric surgery and receiving care at the Duke Metabolic and Weight Loss Surgery Center.
3. Negative pregnancy test in women of childbearing potential (confirmed during screening).
4. Normal lung function.
5. No clinical history of atopy.
6. No significant medical or psychological issues.
7. Healthy subjects able to undergo bronchoscopy without complications.
8. Willing and able to give informed consent and adhere to visit/protocol schedules.
9. Read and write in English.
Exclusion Criteria
2. Adults ≥ 18 years of age with an initial asthma diagnosis at ≥ 12 years of age, as defined by the NHLBI NAEPP guidelines.
3. Inpatient status.
4. FEV1 is less than 45% predicted before, or less than 55% predicted after, bronchodilator administration.
5. Upper or lower respiratory tract infection within one month of the study.
6. Use of inhaled or systemic corticosteroids within four weeks of study.
7. Use of long-acting beta-2, GLP-1 receptor agonists, or dipeptidyl peptidase-4 (DPP-4) inhibitors within two weeks of study.
8. Smoking history \> 5 pack years or any cigarette use within the previous six months.
9. Significant non-asthma pulmonary disease (stable obstructive sleep apnea is not excluded).
10. Positive pregnancy test for women and/or nursing women.
11. An emergency department visit or inpatient admission for a primary respiratory diagnosis or treatment with antibiotics within 60 days of enrollment.
12. Poorly controlled concomitant conditions that pose additional procedure risk as determined by the investigator.
13. All patients on anticoagulants
14. Uncontrolled sleep apnea
15. Use of e-cigarettes or "vape" devices of any kind
18 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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Loretta Que, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke Metabolic and Weight Loss Surgery Center
Durham, North Carolina, United States
Duke Asthma Allergy and Airway Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00077482
Identifier Type: -
Identifier Source: org_study_id
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