Obesity, Metabolic Dysregulation and the Airway Epithelium in Asthmatics

Obesity Clinical Trial

Official title: Obesity, Metabolic Dysregulation and the Airway Epithelium in Asthmatics

Status Recruiting

Clinical Trial Summary

The objective of this pilot study is to determine whether obesity and metabolic syndrome are in fact synergistic in relation to airway nitric oxide (NO) biology. To do so, the investigators want to determine how obesity and the metabolic syndrome relate to metabolism in bronchial airway epithelial cells and the nasal epithelium.

Clinical Trial Description

This is a cross sectional pilot study comparing specific metabolic pathways in bronchial airway epithelial cells and the nasal epithelium across the following patient groups:

1. Obese (Body Mass Index (BMI) ≥ 30) asthmatics without metabolic syndrome,

2. Obese asthmatics with metabolic syndrome,

3. Obese non-asthmatics, and

4. Non - obese (lean > 18 <= 25, Overweight (OW) > 25 - <30) asthmatics.

Participants in these groups will be matched by gender, age and asthma severity. To be enrolled, participants must be non-current smokers and be controlled. After meeting screening criteria, participants will undergo further evaluation to determine whether or not inclusion and exclusion criteria are met. Participants will undergo a baseline evaluation, lung function testing and a subsequent bronchoscopy and nasal epithelial brush sampling in those that meet study enrollment.

Participants without a bronchodilator withhold will be scheduled to undergo a methacholine test. Those that qualify will undergo a bronchoscopy to obtain bronchoalveolar lavage and airway epithelial cells and nasal epithelial brush sampling for gene expression studies. After the procedure is done and post bronchoscopy safety standards are met, participants will be discharged from the inpatient Clinical Translational Research Center (CTRC) recovery area. The research coordinator will call the participant on the night of the procedure and on the next day to document post-procedure clinical stability. ;

Related Conditions & MeSH terms

• Asthma
• Metabolic Syndrome
• Obesity

• NCT number: NCT03215836
• Study type: Interventional
• Source: University of Colorado, Denver
• Contact: Asthma Research
• Phone: 1 (844) 365-0852
• Email: asthmaresearch@ucdenver.edu
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2017
• Completion date: December 31, 2029