Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma

Completed

• Conditions: Asthma; Obesity
• Interventions: Procedure: Blood draw; Procedure: Sputum collection; Procedure: Pulmonary function test

• Registration Number: NCT04247971
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-30
• Study Start: 2021-04-30
• Status Verified: 2023-02
• Primary Completion: 2023-02-09
• Study Completion: 2023-02-09
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese, early-onset asthmatics	Pulmonary function test	Obese adults (BMI\>or= 30) between the ages of 21-60 with an initial asthma diagnosis at \<12 years of age
Obese non-asthmatics	Sputum collection	Obese adults (BMI \> or = 30) between the ages of 21-60 with no asthma diagnosis
Obese non-asthmatics	Pulmonary function test	Obese adults (BMI \> or = 30) between the ages of 21-60 with no asthma diagnosis
Obese, late-onset asthmatics	Blood draw	Obese adults (BMI \> or = 30) between the ages of 21-60 with an initial asthma diagnosis at \>12 years of age
Obese non-asthmatics	Blood draw	Obese adults (BMI \> or = 30) between the ages of 21-60 with no asthma diagnosis
Obese, early-onset asthmatics	Blood draw	Obese adults (BMI\>or= 30) between the ages of 21-60 with an initial asthma diagnosis at \<12 years of age
Obese, late-onset asthmatics	Sputum collection	Obese adults (BMI \> or = 30) between the ages of 21-60 with an initial asthma diagnosis at \>12 years of age
Obese, early-onset asthmatics	Sputum collection	Obese adults (BMI\>or= 30) between the ages of 21-60 with an initial asthma diagnosis at \<12 years of age
Obese, late-onset asthmatics	Pulmonary function test	Obese adults (BMI \> or = 30) between the ages of 21-60 with an initial asthma diagnosis at \>12 years of age

Primary Outcome Measures

Name	Time	Method
Change in leptin 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 YKL-40 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 TNF-α levels	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 IL-8 levels	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
Change in adiponectin 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-1beta 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 fractional concentration of exhaled nitro oxide	Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States