AsthmaNCT04247971
Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma
An observational study of Asthma and Obesity, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Blood draw, Sputum collection and Pulmonary function test
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2021to 9 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Blood draw, Sputum collection, Pulmonary function test
- Medical subject headings
- Asthma, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawProcedure or surgery
23 ml of blood collected
Sputum collectionProcedure or surgery
Induced sputum sample collected
Pulmonary function testProcedure or surgery
Pulmonary function testing
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Procedure: Blood draw; Procedure: Sputum collection; Procedure: Pulmonary function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in leptin levels
Measured: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in adiponectin levels
Measured: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in IL-8 levels
Measured: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in IL-6 levels
Measured: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in cystatin-c levels
Measured: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in IL-17 levels
Measured: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in IL-1beta levels
Measured: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in TNF-α levels
Measured: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in YKL-40 levels
Measured: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by forced expiratory volume
Measured: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by forced vital capacity
Measured: 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
Measured: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by FEV1/FVC
Measured: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by forced expiratory flow
Measured: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start30 Apr 2021
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kunoor Jain-Spangler, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247971
- Sponsor's protocol ID
- Pro00104326
- Status last verified
- Feb 2023
- First submitted
- 27 Jan 2020
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma
- ClinicalTrials.gov ID
- NCT04247971
- Acronym / sponsor ID
- Pro00104326
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese, early-onset asthmatics | – | Procedure: Blood draw, Procedure: Sputum collection, Procedure: Pulmonary function testObese adults (BMI>or= 30) between the ages of 21-60 with an initial asthma diagnosis at <12 years of age |
| Obese, late-onset asthmatics | – | Procedure: Blood draw, Procedure: Sputum collection, Procedure: Pulmonary function testObese adults (BMI > or = 30) between the ages of 21-60 with an initial asthma diagnosis at >12 years of age |
| Obese non-asthmatics | – | Procedure: Blood draw, Procedure: Sputum collection, Procedure: Pulmonary function testObese adults (BMI > or = 30) between the ages of 21-60 with no asthma diagnosis |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw23 ml of blood collected | Procedure or surgery | Obese non-asthmatics, Obese, early-onset asthmatics, Obese, late-onset asthmatics |
| Sputum collectionInduced sputum sample collected | Procedure or surgery | Obese non-asthmatics, Obese, early-onset asthmatics, Obese, late-onset asthmatics |
| Pulmonary function testPulmonary function testing | Procedure or surgery | Obese non-asthmatics, Obese, early-onset asthmatics, Obese, late-onset asthmatics |
Primary outcome
Change in leptin levels
Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in adiponectin levels
Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in IL-8 levels
Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in IL-6 levels
Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in cystatin-c levels
Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in IL-17 levels
Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in IL-1beta levels
Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in TNF-α levels
Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in YKL-40 levels
Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by forced expiratory volume
Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by forced vital capacity
Time frame: 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
Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by FEV1/FVC
Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Change in lung function as measured by forced expiratory flow
Time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kunoor Jain-Spangler, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Obesity, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in leptin levels (time frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.