Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma

NCT04247971 | Completed

• 1 other identifier: Pro00104326
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Obesity

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (3)

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; Procedure: Sputum collection; Procedure: Pulmonary function test

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; Procedure: Sputum collection; Procedure: Pulmonary function test

Obese non-asthmatics

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

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

Interventions

Blood draw PROCEDURE

23 ml of blood collected

Obese non-asthmatics; Obese, early-onset asthmatics; Obese, late-onset asthmatics

Sputum collection PROCEDURE

Induced sputum sample collected

Obese non-asthmatics; Obese, early-onset asthmatics; Obese, late-onset asthmatics

Pulmonary function test PROCEDURE

Pulmonary function testing

Obese non-asthmatics; Obese, early-onset asthmatics; Obese, late-onset asthmatics

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and sputum

MeSH Terms

Conditions

Asthma; Obesity

Interventions

Blood Specimen Collection; Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Kunoor Jain-Spangler, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 30, 2020
• Study Start: April 30, 2021
• Primary Completion: February 9, 2023
• Study Completion: February 9, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)