RecruitingAsthmaObesityMetabolic Syndrome

Obesity, Metabolic Dysregulation and the Airway Epithelium in Asthmatics

Eligible age

18–65 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

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.

Sponsor: University of Colorado, Denver

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.

Where it's recruiting

Colorado

Aurora

Source: ClinicalTrials.gov · NCT03215836 · last updated 2023-02-02