The Effect of Obesity on Lung Functioning

March 27, 2017 updated by: National Jewish Health

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Medical and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Jewish Health

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

January 31, 2006

First Submitted That Met QC Criteria

January 31, 2006

First Posted (Estimate)

February 1, 2006

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJC HS1963

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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