Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT03215836

Conditions

Asthma

Obesity

Metabolic Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Bronchoscopy and Nasal Epithelium Brush Sampling

Study Details

Brief 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.

Conditions

Asthma

Obesity

Metabolic Syndrome

Study ID

NCT03215836

Start date

Aug 10, 2017

Status verified date

Feb, 2023

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Mar 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

For ALL Groups

1. Adequate completion of informed consent process with written documentation
2. Male and female patients, ≥ 18 - 65 years old
3. 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.
4. Specific to Asthma Groups

i. From all racial/ethnic backgrounds with a diagnosis of asthma based on physician diagnosis for >6 months

1. 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.
2. 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 > 40 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.
3. 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 (all groups):

1. 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);
2. Chronic renal failure (creatinine > 2.0) at screening (associated with higher asymmetric dimethylarginine (ADMA) levels);
3. Current statins use (statins lower ADMA levels);
4. On diabetic medications;
5. Positive pregnancy test;
6. Positive urine cotinine and/or urine tetrahydrocannabinol (THC) test;
7. Current or recent (within 30 days) investigational treatment or participation in another interventional research study (including non-pharmacologic interventions);
8. 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.

a. 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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Obese Asthmatics

BMI >/= 30 and without metabolic syndrome

other: Obese Astmatics

BMI >/= 30 and with metabolic syndrome

other: Obese non-asthmatics

BMI >/= 30

other: Non - obese asthmatics

BMI: lean > 20; Normal >/= 20 to <25; overweight </= 25 to < 30;

Interventions

Bronchoscopy and Nasal Epithelium Brush Sampling

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.

Primary outcome measure

  • Measurement of L-arginine-NO biosynthesis pathways in the airway epithelium in obese and non-asthmatics. [ Time Frame: Within 6 months of collection ]
  • Measurement of oxidative stress in the airway epithelium in obese and non-asthmatics. [ Time Frame: Within 6 months of collection ]

Central Contacts and Locations

Central contacts

Locations

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

More Information

Sponsor

University of Colorado, Denver

Last update posted

Feb 2, 2023

Last verified

Feb, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2023-02-02.