Obesity Metabolic Dysregulation and the Airway Epithelium in Asthmatics

  • End date
    Dec 31, 2026
  • participants needed
  • sponsor
    University of Colorado, Denver
Updated on 30 September 2021
body mass index
metabolic syndrome
fasting blood glucose
pulmonary function test
LDL Cholesterol
nitric oxide
airways disease
a 12
antihypertensive drugs
cholesterol level
hdl cholesterol
serum hdl cholesterol


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.


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.

Condition Metabolic syndrome, Asthma, Allergies & Asthma, asthmatic, Metabolic disorder, Asthma (Pediatric), bronchial asthma, Metabolic Disorders, adiposity, Obesity, metabolic syndrome x, Metabolic Syndrome
Treatment Bronchoscopy and Nasal Epithelium Brush Sampling
Clinical Study IdentifierNCT03215836
SponsorUniversity of Colorado, Denver
Last Modified on30 September 2021


Yes No Not Sure

Inclusion Criteria

For ALL Groups
Adequate completion of informed consent process with written documentation
Male and female patients, 18 - 65 years old
Smoking history <10 pack years and no smoking in the last year
Subjects can be included in the study if they are on blood pressure
treatment and are on a diet control/exercise only treatment of diabetes
\. Specific to Asthma Groups
i. From all racial/ethnic backgrounds with a diagnosis of asthma based on
physician diagnosis for >6 months
Specific to Metabolic Syndrome Group. Metabolic syndrome diagnosis based on having at least any three of: a. Triglycerides 150 mg/dl; b. High-density lipoproteins (HDL) cholesterol 50 mg/dl for women and 40 mg/dl for men; c Fasting blood glucose 100 mg/dl; d. Waist circumference > 40 inches males and > 35 inches females); e. Previously diagnosed hypertension or on antihypertensive medication; f. Blood pressure greater than 130/85 on two consecutive measurements
Specific to Non-Metabolic Syndrome Group a. Baseline pre-bronchodilator forced expiratory volume (FEV1) of 50% or greater of predicted with a 12% or greater bronchodilator (BD) response to 4 puffs of albuterol or PC20 methacholine (16 mg) if no BD response; b. BMI 30
Metabolic syndrome diagnosis based on having at least any three of
i. Triglycerides 150 mg/dl; ii. HDL cholesterol 50 mg/dl for women and 40
mg/dl for men; iii. Fasting blood glucose 100 mg/dl; iv. Waist circumference >
inches males and > 35 inches females); v. Previously diagnosed hypertension
or on antihypertensive medication; vi. Blood pressure greater than 130/85 on
two consecutive measurements
\. Specific to Non-Obese Group a. Body Mass Index (BMI) < 30
b. Specific to Non-Asthma Group i. No history of asthma or any other airway
diseases; ii. Pulmonary function test within normal limits; iii. BMI 30

Exclusion Criteria

Significant or uncontrolled concomitant medical illness (PI discretion) including, but not limited to heart disease, cancer, diabetes (HbAc1 > 6.5), renal disease (creatinine > 2.0) at Visit 0, neurological (brain damage) or psychiatric disorder (diagnosed by a mental health professional of behavioral or mental pattern that may cause suffering or a poor ability to function in life)
Chronic renal failure (creatinine > 2.0) at screening (associated with higher asymmetric dimethylarginine (ADMA) levels)
Current statins use (statins lower ADMA levels)
On diabetic medications
Positive pregnancy test
Positive urine cotinine and/or urine tetrahydrocannabinol (THC) test
Current or recent (within 30 days) investigational treatment or participation in another interventional research study (including non-pharmacologic interventions)
Unable or unlikely to complete study assessments or the study intervention (i.e. bronchoscopy) poses undue risk to patient in the opinion of the investigator
Specific to Asthma Groups i. Respiratory tract infection within the last 4 weeks; ii. Oral or systemic corticosteroids (CS) burst within the last 4 weeks; iii. Asthma-related hospitalization within the last 2 months; iv. Asthma-related ER visit within the previous 4 weeks
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note