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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6 months of collection
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 65 years old.
Select...
I have been diagnosed with metabolic syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 6 months of collection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 6 months of collection
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Measurement of mitochondrial density
Measurement of mitochondrial structural differences.
Patterns of Gene expression found in the nasal epithelium.
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
1,738 Previous Clinical Trials
2,149,476 Total Patients Enrolled
20 Trials studying Asthma
2,935 Patients Enrolled for Asthma
National Jewish HealthOTHER
140 Previous Clinical Trials
316,186 Total Patients Enrolled
23 Trials studying Asthma
17,734 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old.My lung function is good and I'm overweight, but I don't have metabolic syndrome.I do not have any major health issues like heart disease, uncontrolled diabetes, kidney problems, or severe mental health conditions.I have smoked less than 10 pack-years and not in the past year.I have been diagnosed with metabolic syndrome.You are pregnant.I have been diagnosed with asthma by a doctor for more than 6 months.I am managing my diabetes with diet and exercise and may be taking medication for high blood pressure.I haven't had a recent respiratory infection, steroid treatment, or asthma-related hospital or ER visits.Your body mass index (BMI) is less than 30.I am taking medication for diabetes.I am currently taking statins.You have tested positive for cotinine or THC in your urine.I have never had asthma or other airway diseases, my lung function is normal, and my BMI is 30 or above.My kidney function is impaired with a creatinine level over 2.0.
Research Study Groups:
This trial has the following groups:- Group 1: Obese Astmatics
- Group 2: Obese non-asthmatics
- Group 3: Non - obese asthmatics
- Group 4: Obese Asthmatics
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for enrolment in this experiment currently available?
"As evidenced on clinicaltrials.gov, this medical study is actively necessitating participants who meet the inclusion criteria; it was first opened to enrollment in August 2017 and has most recently been updated in September 2021."
Answered by AI
Is this research endeavor enrolling individuals aged 20 or over?
"This experiment is enrolling patients of legal age (18+) and below the age of 65."
Answered by AI
How many participants are being admitted to this research trial?
"Affirmative. According to information on the clinicaltrials.gov website, this medical trial is actively recruiting participants for their research. Originally posted on August 10th 2017 and last updated September 17th 2021, 50 volunteers are needed from one site."
Answered by AI
Is it feasible for me to participate in this experiment?
"This medical trial, open to participants aged 18-65 who have obesity, is recruiting up to 50 individuals meeting the following criteria: on blood pressure treatment and diet/exercise only regimen for diabetes; male or female with a history of smoking fewer than 10 pack years in their lifetime and abstaining from tobacco over the last 12 months; any race/ethnicity diagnosed with asthma at least 6 months prior."
Answered by AI
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