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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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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