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.
Key facts
- Who runs it
- University of Colorado, Denver
- Where
- Aurora, United StatesSee the site
- Trial code
- Registry title
- Obesity, Metabolic Dysregulation and the Airway Epithelium in Asthmatics
- Status
- Recruiting
- People taking part
- 50 people, planned
- Started
- 10 Aug 2017
- Expected to end
- 31 Dec 2029
- Type of study
- Interventional, 4 groups
- Treatments tested
- Bronchoscopy and Nasal Epithelium Brush Sampling
- Record updated
- 2 February 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 65, with or without asthma, with or without obesity and metabolic syndrome. It studies how these relate to airway cells and nasal cells.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Asthma groups need a doctor's asthma diagnosis for more than 6 months. Other groups are defined by BMI (below 30 or 30 and above) and by metabolic syndrome (at least three of the listed measures).
- Earlier treatment
- People currently using statins or diabetes medicines cannot join. Blood pressure treatment, or diabetes managed by diet and exercise only, is allowed.
- Biomarker or test result
- Metabolic syndrome means at least three of: triglycerides 150 mg/dl (1.7 mmol/L) or more, low HDL cholesterol, fasting blood glucose 100 mg/dl (5.6 mmol/L) or more, large waist, high blood pressure. HbA1c must not be above 6.5.
Main reasons for not taking part
- Smoking history of 10 pack years or more, or smoking in the last year
- Serious or uncontrolled illness, such as heart disease, cancer, diabetes or kidney disease
- Positive pregnancy test
- Positive urine test for cotinine or THC
- Asthma groups: recent respiratory infection, steroid burst, hospital stay or ER visit for asthma
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
Check if you might fit
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?
Where in United States
- University of ColoradoAurora, United StatesContact: Asthma ResearchTaking people
About the trial
What the trial wants 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.
The 4 groups in the trial
- Obese AsthmaticsOther group
BMI \>/= 30 and without metabolic syndrome
Treatment: Bronchoscopy and Nasal Epithelium Brush Sampling
- Obese AstmaticsOther group
BMI \>/= 30 and with metabolic syndrome
Treatment: Bronchoscopy and Nasal Epithelium Brush Sampling
- Obese non-asthmaticsOther group
BMI \>/= 30
Treatment: Bronchoscopy and Nasal Epithelium Brush Sampling
- Non - obese asthmaticsOther group
BMI: lean \> 20; Normal \>/= 20 to \<25; overweight \</= 25 to \< 30;
Treatment: Bronchoscopy and Nasal Epithelium Brush Sampling
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Obesity, Metabolic Dysregulation and the Airway Epithelium in Asthmatics
- Plain-language title
- Studies airway cells in adults with asthma, obesity and metabolic syndromeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT03215836, who can take part
- Record updated
- 2 February 2023