Clinical trial NCT04247971: Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma
Official title: Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Obesity
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in leptin levels
timeFrame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
measure: Change in adiponectin levels
timeFrame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
measure: Change in IL-8 levels
timeFrame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
measure: Change in IL-6 levels
timeFrame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
measure: Change in cystatin-c levels
timeFrame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
measure: Change in IL-17 levels
timeFrame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
measure: Change in IL-1beta levels
timeFrame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
measure: Change in TNF-α levels
timeFrame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
measure: Change in YKL-40 levels
timeFrame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
measure: Change in lung function as measured by forced expiratory volume
timeFrame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
measure: Change in lung function as measured by forced vital capacity
timeFrame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
measure: Change in lung function as measured by fractional concentration of exhaled nitro oxide
timeFrame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
measure: Change in lung function as measured by FEV1/FVC
timeFrame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
measure: Change in lung function as measured by forced expiratory flow
timeFrame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Kunoor Jain-Spangler, MD
role: PRINCIPAL_INVESTIGATOR
References: