The Effect of Obesity on Lung Functioning

This study has been completed.
Sponsor:
Information provided by:
National Jewish Health
ClinicalTrials.gov Identifier:
NCT00284895
First received: January 31, 2006
Last updated: June 25, 2008
Last verified: June 2008

January 31, 2006
June 25, 2008
November 2005
July 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00284895 on ClinicalTrials.gov Archive Site
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The Effect of Obesity on Lung Functioning
The Effect of Medical and Surgical Weight Loss on Pulmonary Physiology and Airway

This research study is looking at the effects of weight loss, due to surgery or structured weight-loss program 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 may qualify for the participation. Involvement will last about 1 year.

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Observational
Time Perspective: Prospective
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  • Obesity
  • Asthma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2007
July 2007   (final data collection date for primary outcome measure)

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 or structured weight-loss plan.

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00284895
NJC HS1963
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National Jewish Health
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Principal Investigator: David Beuther, MD National Jewish Medical and Research Center faculty
National Jewish Health
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP