Actively Recruiting
Obesity, Metabolic Dysregulation and the Airway Epithelium in Asthmatics
Led by University of Colorado, Denver · Updated on 2023-02-02
50
Participants Needed
1
Research Sites
646 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Jewish Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Obesity, Metabolic Dysregulation and the Airway Epithelium in Asthmatics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed informed consent with written documentation
- Male or female aged 18 to 65 years
- Smoking history less than 10 pack years and no smoking in the past year
- Asthma diagnosis by a physician for more than 6 months (for asthma groups)
- For metabolic syndrome group: diagnosis requires at least three of the following: triglycerides 2150 mg/dl, HDL cholesterol 250 mg/dl for women or 240 mg/dl for men, fasting blood glucose 2100 mg/dl, waist circumference 2 40 inches for males or 2 35 inches for females, diagnosed hypertension or on antihypertensive medication, blood pressure over 130/85 on two measurements
- For non-metabolic syndrome group: pre-bronchodilator FEV1 50% or greater predicted with 12% or greater bronchodilator response or methacholine PC20 16 mg if no bronchodilator response; BMI 230
- For non-obese group: BMI less than 30
- For non-asthma group: no history of asthma or airway disease; normal lung function; BMI 230
- Subjects on blood pressure treatment and diet control/exercise only treatment for diabetes can be included
You will not qualify if you...
- Significant or uncontrolled medical illnesses including heart disease, cancer, diabetes with HbA1c over 6.5, renal disease with creatinine over 2.0, neurological or psychiatric disorders
- Chronic renal failure with creatinine over 2.0
- Current use of statins
- Use of diabetic medications
- Positive pregnancy test
- Positive urine test for cotinine or THC
- Participation in another interventional research study within 30 days
- Unable or unlikely to complete study assessments or bronchoscopy poses undue risk
- For asthma groups: respiratory infection within 4 weeks, oral or systemic corticosteroids within 4 weeks, asthma hospitalization within 2 months, asthma-related emergency room visit within 4 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
A
Asthma Research
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
4
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