Clinical Trial: Contributing Factors in the Pathobiology of Airway Remodeling in Obesity

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Contributing Factors in the Pathobiology of Airway Remodeling in Obesity

Brief Summary: There are two aims for this study. The purpose of this study is to determine the effects of body weight and hormones on airway fibrosis (scarring) and lung function in obese & lean asthma subjects compared to obese & lean non-asthma subjects (Aim 1). And in obese subjects with asthma undergoing bariatric surgery compared to obese non-asthma subjects undergoing bariatric surgery (Aim 2).

Detailed Summary:
Sponsor: Duke University

Current Primary Outcome:

• Airway fibrosis [ Time Frame: Visit 2 (14 days) ]
  Obese asthmatics compared to lean asthmatics, obese non-asthmatics and lean non-asthmatics: A univariate linear model will be constructed to measure the effect of leptin or GLP-1 on airway fibrosis, as measured by the ratio of Masson's trichrome-stained area to non-stained area in the sub-mucosal region of airway biopsy tissue.
• Change in airway fibrosis [ Time Frame: Visit 2 (14 days), Visit 4 (1 year + 14 days) ]
  Asthmatics undergoing bariatric surgery and non-asthmatics undergoing bariatric surgery: Each patient will serve as its own control in comparing pre- and post-operative airway fibrosis. A univariate linear model will be constructed to measure the effect of bariatric surgery on airway fibrosis, as measured by the ratio of Masson's trichrome-stained area to non-stained area in the sub-mucosal region of airway biopsy tissue.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Duke University

Dates:
Date Received: April 4, 2017
Date Started: May 1, 2017
Date Completion: May 1, 2022
Last Updated: April 11, 2017
Last Verified: April 2017