Status:
RECRUITING
Cleaner Air for Lower Cardiometabolic Risk
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Doris Duke Charitable Foundation
Conditions:
PreDiabetes
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05994937
Start Date
December 26 2023
End Date
February 28 2026
Last Update
December 22 2025
Active Locations (1)
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1
NYU Langone Medical Center
New York, New York, United States, 10016