RecruitingNot ApplicableNCT05994937

Cleaner Air for Lower Cardiometabolic Risk

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

Sponsor

NYU Langone Health

Enrollment

160 participants

Start Date

Dec 26, 2023

Study Type

INTERVENTIONAL

Conditions

Prediabetes

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria11

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 Criteria8

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

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Interventions

DEVICEPAC with HEPA filter intact

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.

DEVICEPAC with HEPA filter removed

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.