Obesity, Metabolic Dysregulation and the Airway Epithelium in Asthmatics

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 epithelium.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

⁃ 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

⁃ i. 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:

• 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.

• 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.

Locations
United States
Colorado
University of Colorado
RECRUITING
Aurora
Contact Information
Primary
Asthma Research
asthmaresearch@ucdenver.edu
1 (844) 365-0852
Time Frame
Start Date: 2017-08-10
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 50
Treatments
Other: Obese Asthmatics
BMI \>/= 30 and without metabolic syndrome
Other: Obese Astmatics
BMI \>/= 30 and with metabolic syndrome
Other: Obese non-asthmatics
BMI \>/= 30
Other: Non - obese asthmatics
BMI: lean \> 20; Normal \>/= 20 to \<25; overweight \</= 25 to \< 30;
Sponsors
Collaborators: National Jewish Health
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov