Studies airway cells in adults with asthma, obesity and metabolic syndrome
Samples airway cells to examine how obesity and metabolic syndrome affect asthma-related airway biology.
Plain-language title generated from the registry record
Registry title: Obesity, Metabolic Dysregulation and the Airway Epithelium in Asthmatics
Key facts
- Where
- Aurora, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT03215836, who can take part
Where in United States
- University of ColoradoAurora, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Colorado, Denver
- Trial code
- NCT03215836
- Record updated
- 2 February 2023
- Original description
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.Read full original descriptionShow less
Obesity, Metabolic Dysregulation and the Airway Epithelium in Asthmatics
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.
Inclusion: 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; 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:; 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; Specific to Non-Obese Group a. Body Mass Index (BMI) < 30; 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: On diabetic medications; 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; 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); 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).