Contributing Factors in the Pathobiology of Airway Remodeling in Obesity

STATUS

Recruiting
End date

Apr 13, 2024
participants needed

125
sponsor

Duke University

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Updated on 4 March 2022

See if I qualify

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 Identifier	NCT03115632
Sponsor	Duke University
Last Modified on	4 March 2022

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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

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Contributing Factors in the Pathobiology of Airway Remodeling in Obesity