No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Study type
Interventional
Purpose
Health Services Research
Participants needed
50 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for adults with asthma, obesity, and metabolic syndrome to study how these conditions affect airway health. Participants will undergo assessments related to their breathing and overall health.
Are You a Good Fit for This Trial?
Rules you outHeart diseaseCancerDiabetesRenal diseaseNeurological disorderPsychiatric disorder
You may be able to join if
I am between 18 and 65 years old
I have a diagnosis of asthma for more than 6 months
I have a BMI of 30 or higher
I have been diagnosed with metabolic syndrome
I can provide written consent
I have a smoking history of less than 10 pack years
I am on blood pressure treatment or diet and exercise for diabetes
You may not be able to join if
I have a significant or uncontrolled medical illness
I have chronic renal failure
I am currently using statins
I am on diabetic medicines
I am pregnant
I have tested positive for certain drugs
I participated in another clinical study in the last 30 days
I have had a respiratory infection in the last 4 weeks
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility Criteria
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 pr…
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.
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