The Effect of Obesity on Lung Functioning

Sponsor

National Jewish Health (Other)

Overall Status

Completed

CT.gov ID

NCT00284895

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Asthma

Study Design

Study Type:

Observational

Actual Enrollment :

40 participants

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00284895

Other Study ID Numbers:

NJC HS1963

First Posted:

Feb 1, 2006

Last Update Posted:

Mar 29, 2017

Last Verified:

Mar 1, 2017

Keywords provided by , ,

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Mar 29, 2017