The Effect of Obesity on Lung Functioning - Tabular View

Tracking Information

First Received Date ^ICMJE

January 31, 2006

Last Updated Date

June 25, 2008

Start Date ^ICMJE

November 2005

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00284895 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

The Effect of Obesity on Lung Functioning

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Prospective

Condition ^ICMJE

Obesity
Asthma

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00284895

Responsible Party

Study ID Numbers ^ICMJE

NJC HS1963

Study Sponsor ^ICMJE

National Jewish Health

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

David Beuther, MD

National Jewish Medical and Research Center faculty

Information Provided By

National Jewish Health

Verification Date

June 2008

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