Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma

  • STATUS
    Recruiting
  • days left to enroll
    3
  • participants needed
    60
  • sponsor
    Duke University
Updated on 4 October 2022
bariatric surgery
gastric bypass
sleeve gastrectomy
Accepts healthy volunteers

Summary

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.

Details
Condition Asthma, Obesity
Treatment Blood draw, Pulmonary function test, Sputum collection
Clinical Study IdentifierNCT04247971
SponsorDuke University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
Normal lung function
gastrectomy or duodenal switch) at Duke Regional Hospital and receiving care at the
No clinical history of atopy
Duke Metabolic and -Weight Loss Surgery Center
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
Upper or lower respiratory tract infection within one month of the study
Use of systemic corticosteroids within four weeks of study
Loss Surgery Center
FEV1 is less than 45% predicted before, or less than 55% predicted after
bronchodilator administration
All patients on anticoagulants
Smoking (tobacco, e-cigarette, vaping or inhaled drugs) history > 5 pack years or
Uncontrolled sleep apnea
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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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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