The Effect of Obesity on Lung Functioning

This research study is looking at the effects of weight-reduction surgery on lung function, inflammation in your body and lungs, asthma and asthma symptoms. This study is important because we will be better able to understand the effect of weight on lung functioning and asthma. Approximately 20 research subjects will be enrolling in this study at National Jewish.

Adults with asthma who has elected to undergo weight-reduction surgery msy qualify for the participation. There will be 2 bronchoscopies involved in this study. Involvement will last about 1 year.

Condition
Obesity Weight Loss Surgery Asthma

Further study details as provided by National Jewish Medical and Research Center:

Expected Total Enrollment:  20

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Adults (≥18yr) who report a physician’s diagnosis of asthma and have taken any asthma medication within the last 2 weeks.

• Obesity (Body Mass Index (BMI) ≥40, or ≥35 with comorbidities, as per published guidelines for qualification for bariatric surgery).

• Planned weight-loss surgery.

Exclusion Criteria:

• Tobacco use within one month. • Qualifying lung-functioning. • Qualifying oxygen saturation levels. • Use of systemic corticosteroids (Prednisone) within one month. • Presence of another chronic lung disease besides asthma (COPD, bronchiectasis, ILD, sarcoidosis, etc).

• Presence of another chronic systemic inflammatory disease (rheumatoid arthritis or other connective-tissue disease, chronic infection such as osteomyelitis, inflammatory bowel disease, chronic active hepatitis, etc). Subjects with osteoarthritis, stable coronary artery disease, hypertension, or diabetes mellitus will not be excluded.

• Presence of malignant neoplasm within the last 3 years (with the exception of non-melanoma skin cancer).

• Clinically significant left or right ventricular dysfunction. • Severe pulmonary hypertension (high blood pressure). • Untreated obstructive sleep apnea: • Subjects with a current diagnosis of sleep apnea not being treated with CPAP or BiPAP will be excluded.

• Subjects with a current diagnosis of sleep apnea being treated adequately (as determined by the investigators) will be included.

• Prader-Willi syndrome • A known endocrinopathy causing obesity (e.g., Cushing’s Syndrome).

Please refer to this study by ClinicalTrials.gov identifier  NCT00284895

Jennifer M Brandorff, BA, CIM      303-398-1443    brandorffj@njc.org
Juno Pak, BA      303-398-1443    pakj@njc.org

Colorado
      National Jewish Medical and Research Center, Denver,  Colorado,  80206,  United States; Recruiting

Study chairs or principal investigators

David Beuther, MD,  Principal Investigator,  National Jewish Medical and Research Center faculty   

Study ID Numbers:  NJC HS1963
Last Updated:  January 31, 2006
Record first received:  January 31, 2006
ClinicalTrials.gov Identifier:  NCT00284895
Health Authority: United States: Food and Drug Administration; United States: Office of Human Research Protection