The Effect of Obesity on Lung Functioning

• ClinicalTrials.gov Identifier: NCT00284895
• Recruitment Status: Completed
• First Posted: February 1, 2006
• Last Update Posted: March 29, 2017
• Sponsor: National Jewish Health
• Information provided by: National Jewish Health

Tracking Information

• First Submitted Date: January 31, 2006
• First Posted Date: February 1, 2006
• Last Update Posted Date: March 29, 2017
• Study Start Date: November 2005
• Actual Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Obesity on Lung Functioning
• Official Title: 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: Not Provided
• Study Type: Observational
• Study Design: Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Not Provided
• Study Population: Not Provided

Condition

• Obesity
• Asthma

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 29, 2006): 40
• Original Enrollment (submitted: January 31, 2006): 20
• Actual Study Completion Date: November 2007
• Actual Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00284895
• Other Study ID Numbers: NJC HS1963
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: National Jewish Health
• Collaborators: Not Provided

Investigators

• Principal Investigator: David Beuther, MD; National Jewish Medical and Research Center faculty

• PRS Account: National Jewish Health
• Verification Date: March 2017