Pulmonary Inflammation and Microbiome Changes With Bariatric Surgery in Obese Asthma

February 15, 2023 updated by: Duke University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
23 ml of blood collected
Procedure: Sputum collection
Induced sputum sample collected
Procedure: Pulmonary function test
Pulmonary function testing
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
23 ml of blood collected
Procedure: Sputum collection
Induced sputum sample collected
Procedure: Pulmonary function test
Pulmonary function testing
Obese non-asthmatics
Obese adults (BMI > or = 30) between the ages of 21-60 with no asthma diagnosis
Procedure: Blood draw
23 ml of blood collected
Procedure: Sputum collection
Induced sputum sample collected
Procedure: Pulmonary function test
Pulmonary function testing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in leptin levels
Time Frame: Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery
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
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
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
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
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
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
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
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
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
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
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
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
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
Baseline (2 weeks before surgery), 30 days post-surgery, 3 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kunoor Jain-Spangler, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 9, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 9, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00104326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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