- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00615498
Study to Evaluate the Effects of Weight Loss on Airway Inflammation and Mechanics in Subjects With Asthma (Asthma-Bariatric Surgery Study)
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:
- 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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30308
- Emory University, Emory Crawford Long Hospital, Clinical Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Non-smoker, or a limited smoking history
- Meet criteria for bariatric surgery according to NIH guidelines
Exclusion Criteria:
- Illicit drug use
- Greater than 10 pack-year history of cigarette smoking
- Other significant lung pathology
- Other significant non-pulmonary co-morbidities
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Surgical cases
Subjects who are undergoing bariatric surgery
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Controls
Subjects who qualify for bariatric surgery but do not undergo the procedure
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
Enrollment, 1 month, 6 months, and 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00000064
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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