Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma

Obesity Clinical Trial

Official title:

Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04247971
• Other study ID #: Pro00104326
• Status: Completed
• Start date: April 30, 2021
• Est. completion date: February 9, 2023

Study information

• Verified date: February 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 9, 2023
• Est. primary completion date: February 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Inflammation
• Obesity
• Pneumonia

Intervention

Procedure:
• Blood draw
23 ml of blood collected
• Sputum collection
Induced sputum sample collected
• Pulmonary function test
Pulmonary function testing

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in leptin levels		Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Primary	Change in adiponectin levels		Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Primary	Change in IL-8 levels		Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Primary	Change in IL-6 levels		Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Primary	Change in cystatin-c levels		Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Primary	Change in IL-17 levels		Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Primary	Change in IL-1beta levels		Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Primary	Change in TNF-a levels		Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Primary	Change in YKL-40 levels		Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Primary	Change in lung function as measured by forced expiratory volume		Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Primary	Change in lung function as measured by forced vital capacity		Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Primary	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
Primary	Change in lung function as measured by FEV1/FVC		Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Primary	Change in lung function as measured by forced expiratory flow		Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery