Investigating the effects of obesity and metabolic syndrome on asthma and airway health

Obesity, Metabolic Dysregulation and the Airway Epithelium in Asthmatics

This study is testing how obesity and metabolic syndrome affect asthma and lung health in different groups of people with and without asthma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT03215836 on ClinicalTrials.gov

What this trial studies

This pilot study aims to explore the relationship between obesity, metabolic syndrome, and airway nitric oxide biology in asthmatic patients. It will compare metabolic pathways in bronchial airway epithelial cells and nasal epithelium among four distinct groups: obese asthmatics without metabolic syndrome, obese asthmatics with metabolic syndrome, obese non-asthmatics, and non-obese asthmatics. Participants will undergo lung function testing, bronchoscopy, and nasal epithelial brush sampling to assess gene expression. The study will match participants by gender, age, and asthma severity to ensure comparability.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-65 with a diagnosis of asthma, particularly those who are obese and may or may not have metabolic syndrome.

Not a fit: Patients who are not asthmatic or those with significant smoking history may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of asthma in obese patients with metabolic syndrome.

How similar studies have performed: While this study explores a novel approach, similar studies have indicated potential links between obesity, metabolic syndrome, and respiratory health.

Eligibility criteria

Inclusion Criteria:

For ALL Groups

1. Adequate completion of informed consent process with written documentation
2. Male and female patients, ≥ 18 - 65 years old
3. 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.
4. Specific to Asthma Groups

i. From all racial/ethnic backgrounds with a diagnosis of asthma based on physician diagnosis for \>6 months

1. 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.
2. 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:

   i. 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.
3. Specific to Non-Obese Group a. Body Mass Index (BMI) \< 30

   b. 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.

Exclusion Criteria (all groups):

1. 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);
2. Chronic renal failure (creatinine \> 2.0) at screening (associated with higher asymmetric dimethylarginine (ADMA) levels);
3. Current statins use (statins lower ADMA levels);
4. On diabetic medications;
5. Positive pregnancy test;
6. Positive urine cotinine and/or urine tetrahydrocannabinol (THC) test;
7. Current or recent (within 30 days) investigational treatment or participation in another interventional research study (including non-pharmacologic interventions);
8. 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.

   a. 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.

Where this trial is running

Aurora, Colorado

• University of Colorado — Aurora, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Fernando Holguin, MD, MPH — University of Colorado Denver, Anschutz Medical Campus
• Study coordinator: Asthma Research

Conditions Asthma; Obesity; Metabolic Syndrome