Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Asthma
• Intervention / Treatment: Procedure: Blood draw; Procedure: Sputum collection; Procedure: Pulmonary function test

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cohort of 15-20 obese, early-onset asthmatic, 15-20 obese, late-onset asthmatic, and 15-20 obese non-asthmatic subjects will be recruited. Subjects in each group will undergo an initial screening visit (V0) to establish the subject groups according to asthma diagnosis, asthma onset age and type of scheduled surgery.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obese, early-onset asthmatics; Obese adults (BMI>or= 30) between the ages of 21-60 with an initial asthma diagnosis at <12 years of age	Procedure: Blood draw; 23 ml of blood collected; Procedure: Sputum collection; Induced sputum sample collected; Procedure: Pulmonary function test; Pulmonary function testing
Obese, late-onset asthmatics; Obese adults (BMI > or = 30) between the ages of 21-60 with an initial asthma diagnosis at >12 years of age	Procedure: Blood draw; 23 ml of blood collected; Procedure: Sputum collection; Induced sputum sample collected; Procedure: Pulmonary function test; Pulmonary function testing
Obese non-asthmatics; Obese adults (BMI > or = 30) between the ages of 21-60 with no asthma diagnosis	Procedure: Blood draw; 23 ml of blood collected; Procedure: Sputum collection; Induced sputum sample collected; Procedure: Pulmonary function test; Pulmonary function testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in leptin levels	Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in adiponectin levels	Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in IL-8 levels	Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in IL-6 levels	Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in cystatin-c levels	Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in IL-17 levels	Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in IL-1beta levels	Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in TNF-α levels	Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in YKL-40 levels	Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by forced expiratory volume	Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by forced vital capacity	Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by fractional concentration of exhaled nitro oxide	Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by FEV1/FVC	Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by forced expiratory flow	Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Kunoor Jain-Spangler, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Actual): February 9, 2023
• Study Completion (Actual): February 9, 2023

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Inflammation; Pneumonia; Asthma
• Other Study ID Numbers: Pro00104326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No