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
  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

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

Resource links provided by NLM:


Further study details as provided by National Jewish Health:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by National Jewish Health:
Obesity
Bariatric Surgery
Weight Loss Surgery
Asthma

Additional relevant MeSH terms:
Asthma
Obesity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014