Cleaner Air for Lower Cardiometabolic Risk

Study Overview
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Brief Summary
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The purpose of this interventional sham-controlled pilot study is to study the effects of using portable air cleaners (PACs) in outpatient adults with prediabetes. The primary aims are to determine the effect PAC's have on glycemic variability and the concentrations of circulating biomarkers of inflammation.

Official Title
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Glycemic and Cardiometabolic Biomarker Improvements Associated With Reduction in Air Pollution Exposure

Conditions
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PreDiabetes

Intervention / Treatment
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* Device: PAC with HEPA filter intact
* Device: PAC with HEPA filter removed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is ≥18 years old Participant and members of household are reported to be non-smokers (defined as no household members are currently known to smoke cigarettes or use other tobacco products including e-cigarettes) Participant is to understand/speak English or Spanish Participant can understand study procedures and give informed consent Participant has prediabetes, defined as the absence of diabetes and any of the following: fasting plasma glucose 100-125 mg/dL, 2 hour plasma glucose of 140-199 mg/dL after 75 g oral glucose tolerance test, or A1c 5.7- 6.4%. Able to wear CGM for 2 two-week periods Able to participate in telephone or video conference for home equipment setup if needed Able to visit clinic for blood draws before and after the study period Do not intend to sleep anywhere outside of primary bedroom for more than 48 consecutive hours or a total of 7 days during the study period. Ability to lift, or access to assistance with lifting, 20 lb to set up air filter appliance in bedroom. Have not undergone major dietary change (such as change from usual diet to intermittent fasting or caloric restriction) in the past 2 weeks, and do not intend to during the study period Exclusion Criteria: Participants who have diagnosed diabetes, or take antihyperglycemic medications Participants with known atherosclerotic disease: coronary artery disease, peripheral artery disease or history of cerebrovascular disease (stroke or Transient Ischemic Attack (TIA), carotid stenosis) Participants with known systemic inflammatory conditions (including but not limited to: inflammatory arthritis, vasculitides, inflammatory bowel diseases, cancer within past 5 years, Hashimoto's thyroiditis) Participants currently taking any anti-inflammatory medications or medications that target inflammatory cytokines Pregnancy: because blood glucose problems during pregnancy require intensive monitoring and lifestyle changes to protect the mother and fetus Participants with known or suspected Covid-19 in the prior 30 days Participants with post-covid sequelae (a.k.a Long covid) Participants who are already utilizing HEPA filtration (PAC or within HVAC) in bedrooms

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Portable Air Cleaner (PAC) Filtration<br>High Efficiency Particulate Air (HEPA) filter will be left intact in the PAC for 4 weeks. | Device: PAC with HEPA filter intact<br>* A commercially available PAC with a true HEPA filter will be used. Unit will be placed in the bedroom and used continuously (24 hours/day) for a total of 4 weeks.<br>|
| Sham Comparator: Sham Portable Air Cleaner (PAC) Filtration<br>High Efficiency Particulate Air (HEPA) filter will be removed from the PAC for 4 weeks. | Device: PAC with HEPA filter removed<br>* Uses the same model as the experimental PAC that is identical in appearance and sound with the HEPA filter removed . Unit will be placed in the bedroom and used continuously (24 hours/day) for a total of 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in A Continuous Glucose Monitor (CGM) Coefficient of Variation (CV) | A CGM will be placed at baseline to continuously measure glucose, which will then be used to assess glycemic variability at the end of 4 weeks post-intervention. This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100% | Baseline, Week 4 | 
| Percent Change of C-reactive Protein (CRP) Biomarkers | This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100% | Baseline, Week 4 | 
| Percent Change in Concentration of Interleukin-6 (IL-6) Biomarkers | This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100% | Baseline, Week 4 | 
| Percent Change in Concentration of Tumor Necrosis Factor-alpha (TNFα) Biomarkers | This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100% | Baseline, Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Air pollution, prediabetes, inflammation, cardiovascular disease prevention, blood sugar