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Metabolic Changes in Asthma

N/A
Recruiting
Led By Fernando Holguin, MD, MPH
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female patients, ≥ 18 - 65 years old
Metabolic syndrome diagnosis based on having at least any three of: Triglycerides ≥ 150 mg/dl; High-density lipoproteins (HDL) cholesterol ≤ 50 mg/dl for women and ≤ 40 mg/dl for men; Fasting blood glucose ≥ 100 mg/dl; Waist circumference > 40 inches males and > 35 inches females; Previously diagnosed hypertension or on antihypertensive medication; Blood pressure greater than 130/85 on two consecutive measurements (Specific to Metabolic Syndrome Group)
Must not have
Respiratory tract infection within the last 4 weeks; Oral or systemic corticosteroids (CS) burst within the last 4 weeks; Asthma-related hospitalization within the last 2 months; Asthma-related ER visit within the previous 4 weeks (Specific to Asthma Groups)
On diabetic medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6 months of collection
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether obesity and metabolic syndrome have a combined effect on airway nitric oxide metabolism.

Who is the study for?
This trial is for adults aged 18-65 with asthma, obesity (BMI ≥ 30), and possibly metabolic syndrome. Asthmatics must have had a diagnosis for over 6 months, non-smokers for at least a year, and certain lung function criteria. People with recent respiratory issues, hospital visits due to asthma, or on specific medications like corticosteroids or statins cannot join.
What is being tested?
The study aims to understand the relationship between obesity/metabolic syndrome and airway nitric oxide in asthmatics by sampling cells from the bronchial airway epithelium and nasal epithelium through bronchoscopy.
What are the potential side effects?
Bronchoscopy may cause discomfort in the throat, coughing, gagging during the procedure; there's also a small risk of bleeding or infection where cells are sampled.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been diagnosed with metabolic syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had a recent respiratory infection, steroid treatment, or asthma-related hospital or ER visits.
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I am taking medication for diabetes.
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My kidney function is impaired with a creatinine level over 2.0.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 6 months of collection
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 months of collection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measurement of L-arginine-NO biosynthesis pathways in the airway epithelium in obese and non-asthmatics.
Measurement of oxidative stress in the airway epithelium in obese and non-asthmatics.
Secondary study objectives
Measurement of mitochondrial density
Measurement of mitochondrial structural differences.
Patterns of Gene expression found in the nasal epithelium.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Obese non-asthmaticsExperimental Treatment1 Intervention
BMI \>/= 30
Group II: Obese AstmaticsExperimental Treatment1 Intervention
BMI \>/= 30 and with metabolic syndrome
Group III: Obese AsthmaticsExperimental Treatment1 Intervention
BMI \>/= 30 and without metabolic syndrome
Group IV: Non - obese asthmaticsExperimental Treatment1 Intervention
BMI: lean \> 20; Normal \>/= 20 to \<25; overweight \</= 25 to \< 30;

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,920,050 Total Patients Enrolled
20 Trials studying Asthma
2,935 Patients Enrolled for Asthma
National Jewish HealthOTHER
144 Previous Clinical Trials
317,324 Total Patients Enrolled
24 Trials studying Asthma
18,809 Patients Enrolled for Asthma
Fernando Holguin, MD, MPHPrincipal InvestigatorUniversity of Colorado Denver, Anschutz Medical Campus
7 Previous Clinical Trials
619 Total Patients Enrolled
7 Trials studying Asthma
619 Patients Enrolled for Asthma

Media Library

Obese Astmatics Clinical Trial Eligibility Overview. Trial Name: NCT03215836 — N/A
Asthma Research Study Groups: Obese Astmatics, Obese non-asthmatics, Non - obese asthmatics, Obese Asthmatics
Asthma Clinical Trial 2023: Obese Astmatics Highlights & Side Effects. Trial Name: NCT03215836 — N/A
Obese Astmatics 2023 Treatment Timeline for Medical Study. Trial Name: NCT03215836 — N/A
~11 spots leftby Mar 2027
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