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The Effect of Obesity on Lung Functioning

This study has been completed.

Sponsored by: National Jewish Medical and Research Center
Information provided by: National Jewish Medical and Research Center
ClinicalTrials.gov Identifier: NCT00284895
  Purpose

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.


Condition
Obesity
Asthma

MedlinePlus related topics:   Asthma    Obesity    Weight Control   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Prospective
Official Title:   The Effect of Medical and Surgical Weight Loss on Pulmonary Physiology and Airway

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

Estimated Enrollment:   40
Study Start Date:   November 2005
Study Completion Date:   November 2007
Primary Completion Date:   July 2007 (Final data collection date for primary outcome measure)

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 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).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284895

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

Sponsors and Collaborators
National Jewish Medical and Research Center

Investigators
Principal Investigator:     David Beuther, MD     National Jewish Medical and Research Center faculty    
  More Information


Study ID Numbers:   NJC HS1963
First Received:   January 31, 2006
Last Updated:   June 25, 2008
ClinicalTrials.gov Identifier:   NCT00284895
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Jewish Medical and Research Center:
Obesity  
Bariatric Surgery  
Weight Loss Surgery  
Asthma  

Study placed in the following topic categories:
Obesity
Asthma
Overweight
Body Weight
Signs and Symptoms
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Weight Loss
Hypersensitivity, Immediate
Nutrition Disorders
Overnutrition
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on October 07, 2008




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