AsthmaNCT03215836
Obesity, Metabolic Dysregulation and the Airway Epithelium in Asthmatics
A study testing Bronchoscopy and Nasal Epithelium Brush Sampling in people with Asthma and Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma, Obesity, Metabolic Syndrome
- What is being tested?
- Bronchoscopy and Nasal Epithelium Brush Sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2017to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 join
- 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);
- On diabetic medications;
- Positive pregnancy test;
- Positive urine cotinine and/or urine tetrahydrocannabinol (THC) test;
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- Current or recent (within 30 days) investigational treatment or participation in another interventional research study (including non-pharmacologic interventions);
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Asthma Research, 844-365-0852, asthmaresearch@ucdenver.edu
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.
Read the detailed description
This is a cross sectional pilot study comparing specific metabolic pathways in bronchial airway epithelial cells and the nasal epithelium across the following patient groups:
- Obese (Body Mass Index (BMI) ≥ 30) asthmatics without metabolic syndrome,
- Obese asthmatics with metabolic syndrome,
- Obese non-asthmatics, and
- Non - obese (lean > 18 <= 25, Overweight (OW) > 25 - <30) asthmatics.
Participants in these groups will be matched by gender, age and asthma severity. To be enrolled, participants must be non-current smokers and be controlled. After meeting screening criteria, participants will undergo further evaluation to determine whether or not inclusion and exclusion criteria are met. Participants will undergo a baseline evaluation, lung function testing and a subsequent bronchoscopy and nasal epithelial brush sampling in those that meet study enrollment.
Participants without a bronchodilator withhold will be scheduled to undergo a methacholine test. Those that qualify will undergo a bronchoscopy to obtain bronchoalveolar lavage and airway epithelial cells and nasal epithelial brush sampling for gene expression studies. After the procedure is done and post bronchoscopy safety standards are met, participants will be discharged from the inpatient Clinical Translational Research Center (CTRC) recovery area. The research coordinator will call the participant on the night of the procedure and on the next day to document post-procedure clinical stability.
- Conditions
- Asthma, Obesity, Metabolic Syndrome
- Being tested
- Bronchoscopy and Nasal Epithelium Brush Sampling
- Medical subject headings
- Asthma, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopy and Nasal Epithelium Brush SamplingProcedure or surgery
After meeting screening criteria, participants will undergo further evaluation to determine whether or not inclusion and exclusion criteria are met. Participants will undergo a baseline evaluation, lung function testing and a subsequent bronchoscopy and nasal epithelial brush sampling in those that meet study enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Obese Asthmatics | Other | BMI >/= 30 and without metabolic syndrome Receives: Procedure: Bronchoscopy and Nasal Epithelium Brush Sampling |
| Obese Astmatics | Other | BMI >/= 30 and with metabolic syndrome Receives: Procedure: Bronchoscopy and Nasal Epithelium Brush Sampling |
| Obese non-asthmatics | Other | BMI >/= 30 Receives: Procedure: Bronchoscopy and Nasal Epithelium Brush Sampling |
| Non - obese asthmatics | Other | BMI: lean > 20; Normal >/= 20 to <25; overweight </= 25 to < 30; Receives: Procedure: Bronchoscopy and Nasal Epithelium Brush Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of L-arginine-NO biosynthesis pathways in the airway epithelium in obese and non-asthmatics.
L-arginine-NO biosynthesis pathways will be measured in the airway epithelium of mild to moderate controlled obese and non-obese asthmatics with metabolic syndrome by ELISA and western blot analysis.
Measured: Within 6 months of collection
Measurement of oxidative stress in the airway epithelium in obese and non-asthmatics.
Oxidative stress will be measured in the airway epithelium of mild to moderate controlled obese and non-obese asthmatics without metabolic syndrome by Griess Reaction and western blot analysis.
Measured: Within 6 months of collection
Secondary outcomes (3)
Measurement of mitochondrial density
Mitochondrial density will be measured from cells obtained by one time pulmonary lavage during bronchoscopy.
Measured: Within 6 months of collection
Measurement of mitochondrial structural differences.
Mitochondrial structural differences will be measured from cells obtained by one time pulmonary lavage during bronchoscopy.
Measured: Within 6 months of collection
Patterns of Gene expression found in the nasal epithelium.
Nasal epithelial cells will be obtained by one time nasal brushings and gene expression patterns will be evaluated.
Measured: Within 6 months of collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start10 Aug 2017
- Primary completion10 Mar 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This is a cross sectional pilot study comparing specific metabolic pathways in bronchial airway epithelial cells and the nasal epithelium across the following patient groups: 1. Obese (BMI ≥ 30) asthmatics without metabolic syndrome, 2. Obese asthmatics with metabolic syndrome, 3. Obese non-asthmatics, and 4. Non - obese (lean \> 18 \<= 25, OW \> 25 - \<30) asthmatics.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Jewish Health
- Responsible party
- Sponsor
- Investigators
- Fernando Holguin, MD, MPH, Principal investigator, University of Colorado Denver, Anschutz Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215836
- Sponsor's protocol ID
- 16-2522
- Status last verified
- Feb 2023
- First submitted
- 12 Jun 2017
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Airway epithelial cells, serum samples and bronchoalveolar lavage (BAL) fluid and BAL cells being collected under this protocol will be collected in UC Denver and sent to National Jewish Hospital (NJH) as per agreed protocols. Specimens/instruments will be completely de-identified and the only data that will be sent to Hong Wei Chu's lab at National Jewish Hospital (NJH) will be specimens labeled with a code.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity, Metabolic Dysregulation and the Airway Epithelium in Asthmatics
- ClinicalTrials.gov ID
- NCT03215836
- Acronym / sponsor ID
- 16-2522
- Conditions
- Asthma, Obesity, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Jewish Health
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 10 Mar 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a cross sectional pilot study comparing specific metabolic pathways in bronchial airway epithelial cells and the nasal epithelium across the following patient groups:
- Obese (Body Mass Index (BMI) ≥ 30) asthmatics without metabolic syndrome,
- Obese asthmatics with metabolic syndrome,
- Obese non-asthmatics, and
- Non - obese (lean > 18 <= 25, Overweight (OW) > 25 - <30) asthmatics.
Participants in these groups will be matched by gender, age and asthma severity. To be enrolled, participants must be non-current smokers and be controlled. After meeting screening criteria, participants will undergo further evaluation to determine whether or not inclusion and exclusion criteria are met. Participants will undergo a baseline evaluation, lung function testing and a subsequent bronchoscopy and nasal epithelial brush sampling in those that meet study enrollment.
Participants without a bronchodilator withhold will be scheduled to undergo a methacholine test. Those that qualify will undergo a bronchoscopy to obtain bronchoalveolar lavage and airway epithelial cells and nasal epithelial brush sampling for gene expression studies. After the procedure is done and post bronchoscopy safety standards are met, participants will be discharged from the inpatient Clinical Translational Research Center (CTRC) recovery area. The research coordinator will call the participant on the night of the procedure and on the next day to document post-procedure clinical stability.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a cross sectional pilot study comparing specific metabolic pathways in bronchial airway epithelial cells and the nasal epithelium across the following patient groups: 1. Obese (BMI ≥ 30) asthmatics without metabolic syndrome, 2. Obese asthmatics with metabolic syndrome, 3. Obese non-asthmatics, and 4. Non - obese (lean > 18 <= 25, OW > 25 - <30) asthmatics.
| Arm | Type | Receives |
|---|---|---|
| Obese Asthmatics | Other | Procedure: Bronchoscopy and Nasal Epithelium Brush SamplingBMI >/= 30 and without metabolic syndrome |
| Obese Astmatics | Other | Procedure: Bronchoscopy and Nasal Epithelium Brush SamplingBMI >/= 30 and with metabolic syndrome |
| Obese non-asthmatics | Other | Procedure: Bronchoscopy and Nasal Epithelium Brush SamplingBMI >/= 30 |
| Non - obese asthmatics | Other | Procedure: Bronchoscopy and Nasal Epithelium Brush SamplingBMI: lean > 20; Normal >/= 20 to <25; overweight </= 25 to < 30; |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (9 listed)
- 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);
- On diabetic medications;
- Positive pregnancy test;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoscopy and Nasal Epithelium Brush SamplingAfter meeting screening criteria, participants will undergo further evaluation to determine whether or not inclusion and exclusion criteria are met. Participants will undergo a baseline evaluation, lung function testing and a subsequent bronchoscopy and nasal epithelial brush sampling in those that meet study enrollment. | Procedure or surgery | Non - obese asthmatics, Obese Asthmatics, Obese Astmatics, Obese non-asthmatics |
Primary outcome
Measurement of L-arginine-NO biosynthesis pathways in the airway epithelium in obese and non-asthmatics.
Time frame: Within 6 months of collection
L-arginine-NO biosynthesis pathways will be measured in the airway epithelium of mild to moderate controlled obese and non-obese asthmatics with metabolic syndrome by ELISA and western blot analysis.
Measurement of oxidative stress in the airway epithelium in obese and non-asthmatics.
Time frame: Within 6 months of collection
Oxidative stress will be measured in the airway epithelium of mild to moderate controlled obese and non-obese asthmatics without metabolic syndrome by Griess Reaction and western blot analysis.
3 secondary outcomes
Measurement of mitochondrial density
Time frame: Within 6 months of collection
Measurement of mitochondrial structural differences.
Time frame: Within 6 months of collection
Patterns of Gene expression found in the nasal epithelium.
Time frame: Within 6 months of collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: Undecided. Airway epithelial cells, serum samples and bronchoalveolar lavage (BAL) fluid and BAL cells being collected under this protocol will be collected in UC Denver and sent to National Jewish Hospital (NJH) as per agreed protocols. Specimens/instruments will be completely de-identified and the only data that will be sent to Hong Wei Chu's lab at National Jewish Hospital (NJH) will be specimens labeled with a code.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernando Holguin, MD, MPH principal investigator
University of Colorado Denver, Anschutz Medical Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy and Nasal Epithelium Brush Sampling in people with Asthma and Obesity, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asthma Research (1 (844) 365-0852, asthmaresearch@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of L-arginine-NO biosynthesis pathways in the airway epithelium in obese and non-asthmatics. (time frame: Within 6 months of collection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.