Study to Evaluate the Effects of Weight Loss on Airway Inflammation and Mechanics in Subjects With Asthma (Asthma-Bariatric Surgery Study)
|ClinicalTrials.gov Identifier: NCT00615498|
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : July 31, 2013
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Study to Evaluate the Effects of Weight Loss on Airway Inflammation and Mechanics in Subjects With Asthma|
|Study Start Date :||July 2006|
|Primary Completion Date :||September 2008|
|Study Completion Date :||September 2008|
Subjects who are undergoing bariatric surgery
Subjects who qualify for bariatric surgery but do not undergo the procedure
- 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 ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615498
|United States, Georgia|
|Emory University, Emory Crawford Long Hospital, Clinical Research Center|
|Atlanta, Georgia, United States, 30308|