Study to Evaluate the Effects of Weight Loss on Airway Inflammation and Mechanics in Subjects With Asthma (Asthma-Bariatric Surgery Study)

NCT00615498 | Completed

• 1 other identifier: IRB00000064
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Asthma

Keywords

Asthma, obesity, bariatric

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Enrollment, 1 month, 6 months, and 1 year

Study Arms (2)

Surgical cases

Subjects who are undergoing bariatric surgery

Controls

Subjects who qualify for bariatric surgery but do not undergo the procedure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese asthmatics

You may qualify if:

• Non-smoker, or a limited smoking history
• Meet criteria for bariatric surgery according to NIH guidelines

You may not qualify if:

• Illicit drug use
• Greater than 10 pack-year history of cigarette smoking
• Other significant lung pathology
• Other significant non-pulmonary co-morbidities

Sponsors & Collaborators

• Emory University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Emory University, Emory Crawford Long Hospital, Clinical Research Center

Atlanta, Georgia, 30308, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and exhaled breath condensate samples will obtained at all time points (baseline, 1 month, 6 months, and 1 year.

MeSH Terms

Conditions

Asthma; Obesity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 14, 2008
• Study Start: July 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 31, 2013

Record last verified: 2013-07

Locations

US (1)