The Effect of Obesity on Lung Functioning

Obesity Clinical Trial

Official title:

The Effect of Medical and Surgical Weight Loss on Pulmonary Physiology and Airway

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284895
• Other study ID #: NJC HS1963
• Status: Completed
• Phase: N/A
• First received: January 31, 2006
• Last updated: March 27, 2017
• Start date: November 2005
• Est. completion date: November 2007

Study information

• Verified date: March 2017
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Asthma
• Obesity

Locations

Country	Name	City	State
United States	National Jewish Medical and Research Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Country where clinical trial is conducted

United States,