Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma

Duke University

Status: Completed

Conditions: Asthma; Obesity

Treatments: Procedure: Blood draw; Procedure: Pulmonary function test; Procedure: Sputum collection

Study type: Observational

Funder types: Other

Identifiers

NCT04247971

Pro00104326

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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 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

• Children < 21 years of age.
• 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.

Trial design

16 participants in 3 patient groups

Obese, early-onset asthmatics

Description:

Obese adults (BMI\>or= 30) between the ages of 21-60 with an initial asthma diagnosis at \<12 years of age

Treatment:

Procedure: Pulmonary function test

Procedure: Sputum collection

Procedure: Blood draw

Obese, late-onset asthmatics

Description:

Obese adults (BMI \> or = 30) between the ages of 21-60 with an initial asthma diagnosis at \>12 years of age

Treatment:

Procedure: Pulmonary function test

Procedure: Sputum collection

Procedure: Blood draw

Obese non-asthmatics

Description:

Obese adults (BMI \> or = 30) between the ages of 21-60 with no asthma diagnosis

Treatment:

Procedure: Pulmonary function test

Procedure: Sputum collection

Procedure: Blood draw