Contributing Factors in the Pathobiology of Airway Remodeling in Obesity

  • STATUS
    Recruiting
  • End date
    Apr 13, 2024
  • participants needed
    125
  • sponsor
    Duke University
Updated on 4 March 2022
body mass index
pulmonary function test
bronchodilator
forced expiratory volume
atopy
airway remodelling
bariatric surgery
Accepts healthy volunteers

Summary

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).

Description

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◦

Details
Condition Asthma, Obesity, Obesity, Morbid, Bariatric Surgery Candidate
Clinical Study IdentifierNCT03115632
SponsorDuke University
Last Modified on4 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Obese asthmatic & lean asthmatic
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
Lean subjects with body mass index (BMI) ≥ 20 kg/m2 and < 30 kg/m2 or obese subjects with BMI ≥ 30 and ≤ 55 kg/m2
Physician diagnosis of asthma
Forced expiratory volume at one second (FEV1) within acceptable limits (>45% predicted before and >55% predicted after, bronchodilator administration)
Negative pregnancy test in women of childbearing potential (confirmed during screening)
Relatively healthy subjects able to undergo bronchoscopy without complications
Willing and able to give informed consent and adhere to visit/protocol schedules
Read and write in English
Obese non-asthmatic & Lean non-asthmatic
Outpatient adults of either sex 18-60 years of age
Lean subjects with body mass index (BMI) ≥ 20 kg/m2 and < 30 kg/m2 or obese subjects with BMI ≥ 30 and ≤ 55 kg/m2
Negative pregnancy test in women of childbearing potential (confirmed during screening)
Normal lung function
No clinical history of atopy
No significant medical or psychological issues
Healthy subjects able to undergo bronchoscopy without complications
Willing and able to give informed consent and adhere to visit/protocol schedules
Read and write in English
Asthmatic undergoing bariatric surgery
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
Physician diagnosis of asthma
FEV1 within acceptable limits (>45% predicted before and >55% predicted after, bronchodilator administration)
Morbidly obese subjects undergoing bariatric surgery and receiving care at the Duke Metabolic and Weight Loss Surgery Center
Negative pregnancy test in women of childbearing potential (confirmed during screening)
Relatively healthy subjects able to undergo bronchoscopy without complications
Willing and able to give informed consent and adhere to visit/protocol schedules
Read and write in English
Non-Asthmatic undergoing bariatric surgery
Outpatient adults of either sex 18-60 years of age
Morbidly obese subjects undergoing bariatric surgery and receiving care at the Duke Metabolic and Weight Loss Surgery Center
Negative pregnancy test in women of childbearing potential (confirmed during screening)
Normal lung function
No clinical history of atopy
No significant medical or psychological issues
Healthy subjects able to undergo bronchoscopy without complications
Willing and able to give informed consent and adhere to visit/protocol schedules
Read and write in English

Exclusion Criteria

Children < 18 years of age
Adults ≥ 18 years of age with an initial asthma diagnosis at ≥ 12 years of age, as defined by the NHLBI NAEPP guidelines
Inpatient status
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 inhaled or systemic corticosteroids within four weeks of study
Use of long-acting beta-2, GLP-1 receptor agonists, or dipeptidyl peptidase-4 (DPP-4) inhibitors within two weeks of study
Smoking history > 5 pack years or any cigarette use within the previous six months
Significant non-asthma pulmonary disease (stable obstructive sleep apnea is not excluded)
Positive pregnancy test for women and/or nursing women
An emergency department visit or inpatient admission for a primary respiratory diagnosis or treatment with antibiotics 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
Use of e-cigarettes or "vape" devices of any kind
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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