AsthmaNCT00615498
Study to Evaluate the Effects of Weight Loss on Airway Inflammation and Mechanics in Subjects With Asthma (Asthma-Bariatric Surgery Study)
An observational study of Asthma, run by Emory University at 1 site in United States.
Trial summary
Current research shows that obesity greatly increases the risk of developing asthma. Although the two conditions are clearly related, experts do not fully understand why they are linked. Some researchers believe that hormones released in the fat cells (adipokines) play a role. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Sep 2008
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese asthmatics
Who may be able to join
- Non-smoker, or a limited smoking history
- Meet criteria for bariatric surgery according to NIH guidelines
Who cannot join
- Illicit drug use
- Greater than 10 pack-year history of cigarette smoking
- Other significant lung pathology
- Other significant non-pulmonary co-morbidities
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University, Emory Crawford Long Hospital, Clinical Research Center
Atlanta, Georgia, 30308
About this study
Official title: Study to Evaluate the Effects of Weight Loss on Airway Inflammation and Mechanics in Subjects With Asthma
Current research shows that obesity greatly increases the risk of developing asthma. Although the two conditions are clearly related, experts do not fully understand why they are linked. Some researchers believe that hormones released in the fat cells (adipokines) play a role. Others believe that excess weight pressing on the lungs triggers the hyperreactive response in the airways that is typical of asthma.
The goal of the Asthma-Bariatric Surgery Study is to determine how weight loss affects lung function and various biological parameters. Bariatric (weight loss) surgery refers to the various surgical procedures performed to treat obesity. Specifically, this study is designed to answer the following questions:
Read more
- Does bariatric surgery help patients control their asthma?
- How much asthma control can be achieved through weight loss?
- How does weight loss influence lung function?
Participants in this observational research study will be asked to complete study visits at enrollment, 1 month, 6 months, and 12 months. Questionnaires, pulmonary function tests, and blood samples will be required at each time point.
This research study is observational only; it does not cover the cost of (or provide) bariatric surgery. Optional genetic and bronchoscopy substudies are included as well.
Read the detailed description
This study is designed to explain the unexpected effects of obesity on NO bioavailability in the airways of asthmatics: Specifically, that obesity induces systemic oxidative stress in part through increased production of reactive oxygen species (ROS) in adipose tissue and, in parallel (or as a consequence), increased systemic levels of tumor necrosis factor (TNF-α)and 8-isoprostanes. Furthermore, it creates an imbalance in the regulation of protective anti-oxidant thiol/disulfide pairs such as glutathione/glutathione disulfide. We hypothesize that in asthmatics, the lung is a target-organ of this obesity-related systemic oxidative stress. This is manifested as increased oxidation of airway NO into nitrate and reactive nitrogen species (RNS) including peroxynitrate and nitrotyrosine, thereby reducing NO bioavailability and exhaled NO levels. NO has many key physiological properties including bronchodilation, anti-tumoral/bactericidal activity, and anti-inflammatory and anti-oxidative activity. Thus, reduced NO bioavailability in obese asthmatics could favor increased bronchoconstriction and impair the lung's ability to respond to further oxidative or inflammatory challenges. Therefore, we hypothesize that: 1) obesity causes redox stress in the airway, which in turn decreases the bioavailability of NO by shunting it into RNS, 2) that weight loss will decrease systemic oxidative stress and thereby increase NO bioavailability due to decreased oxidation into RNS, and 3) that by decreasing systemic oxidative stress, weight loss will reduce bronchial hyper-reactivity.
- Conditions
- Asthma
- Keywords
- Asthma, obesity, bariatric
- Medical subject headings
- Asthma, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical cases | Subjects who are undergoing bariatric surgery | |
| Controls | Subjects who qualify for bariatric surgery but do not undergo the procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure levels of exhaled nitric oxide, reactive nitrogen species, exhaled biomarkers of lipid peroxidation, asthma quality of life, airway function (spirometry and response to methacholine), and degree of asthma control
Measured: Enrollment, 1 month, 6 months, and 1 year
To measure systemic markers of redox stress and inflammation, including plasma levels of adipokines, adiposity-related cytokines (IL-6, TNF-α), GSH/GSSG, 8-isoprostanes, and leukotrienes
Measured: Enrollment, 1 month, 6 months, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startJul 2006
- Primary completionSep 2008
- Study completionSep 2008
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 Emory 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615498
- Sponsor's protocol ID
- IRB00000064
- Status last verified
- Jul 2013
- First submitted
- 4 Feb 2008
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Effects of Weight Loss on Airway Inflammation and Mechanics in Subjects With Asthma
- ClinicalTrials.gov ID
- NCT00615498
- Acronym / sponsor ID
- IRB00000064
- Conditions
- Asthma
- Keywords
- Asthma, obesity, bariatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 14 Feb 2008 (estimated)
- 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.
Current research shows that obesity greatly increases the risk of developing asthma. Although the two conditions are clearly related, experts do not fully understand why they are linked. Some researchers believe that hormones released in the fat cells (adipokines) play a role. Others believe that excess weight pressing on the lungs triggers the hyperreactive response in the airways that is typical of asthma.
The goal of the Asthma-Bariatric Surgery Study is to determine how weight loss affects lung function and various biological parameters. Bariatric (weight loss) surgery refers to the various surgical procedures performed to treat obesity. Specifically, this study is designed to answer the following questions:
- Does bariatric surgery help patients control their asthma?
- How much asthma control can be achieved through weight loss?
- How does weight loss influence lung function?
Participants in this observational research study will be asked to complete study visits at enrollment, 1 month, 6 months, and 12 months. Questionnaires, pulmonary function tests, and blood samples will be required at each time point.
This research study is observational only; it does not cover the cost of (or provide) bariatric surgery. Optional genetic and bronchoscopy substudies are included as well.
Detailed description
This study is designed to explain the unexpected effects of obesity on NO bioavailability in the airways of asthmatics: Specifically, that obesity induces systemic oxidative stress in part through increased production of reactive oxygen species (ROS) in adipose tissue and, in parallel (or as a consequence), increased systemic levels of tumor necrosis factor (TNF-α)and 8-isoprostanes. Furthermore, it creates an imbalance in the regulation of protective anti-oxidant thiol/disulfide pairs such as glutathione/glutathione disulfide. We hypothesize that in asthmatics, the lung is a target-organ of this obesity-related systemic oxidative stress. This is manifested as increased oxidation of airway NO into nitrate and reactive nitrogen species (RNS) including peroxynitrate and nitrotyrosine, thereby reducing NO bioavailability and exhaled NO levels. NO has many key physiological properties including bronchodilation, anti-tumoral/bactericidal activity, and anti-inflammatory and anti-oxidative activity. Thus, reduced NO bioavailability in obese asthmatics could favor increased bronchoconstriction and impair the lung's ability to respond to further oxidative or inflammatory challenges. Therefore, we hypothesize that: 1) obesity causes redox stress in the airway, which in turn decreases the bioavailability of NO by shunting it into RNS, 2) that weight loss will decrease systemic oxidative stress and thereby increase NO bioavailability due to decreased oxidation into RNS, and 3) that by decreasing systemic oxidative stress, weight loss will reduce bronchial hyper-reactivity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical cases | – | –Subjects who are undergoing bariatric surgery |
| Controls | – | –Subjects who qualify for bariatric surgery but do not undergo the procedure |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese asthmatics
Key inclusion criteria (2 listed)
- Non-smoker, or a limited smoking history
- Meet criteria for bariatric surgery according to NIH guidelines
Key exclusion criteria (4 listed)
- Illicit drug use
- Greater than 10 pack-year history of cigarette smoking
- Other significant lung pathology
- Other significant non-pulmonary co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To measure levels of exhaled nitric oxide, reactive nitrogen species, exhaled biomarkers of lipid peroxidation, asthma quality of life, airway function (spirometry and response to methacholine), and degree of asthma control
Time frame: Enrollment, 1 month, 6 months, and 1 year
To measure systemic markers of redox stress and inflammation, including plasma levels of adipokines, adiposity-related cytokines (IL-6, TNF-α), GSH/GSSG, 8-isoprostanes, and leukotrienes
Time frame: Enrollment, 1 month, 6 months, and 1 year
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 31 Jul 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Emory 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 2 inclusion and 4 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 31 Jul 2013. 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?
To measure levels of exhaled nitric oxide, reactive nitrogen species, exhaled biomarkers of lipid peroxidation, asthma quality of life, airway function (spirometry and response to methacholine), and degree of asthma control (time frame: Enrollment, 1 month, 6 months, and 1 year). The study lists 2 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 31 Jul 2013.