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OpenTrials
Completed

NCT Number: NCT05994937

Cleaner Air for Lower Cardiometabolic Risk

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Medical Center

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAC with HEPA filter intact

Device

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.

PAC with HEPA filter removed

Device

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.

Primary outcomes

  1. Percent Change in A Continuous Glucose Monitor (CGM) Coefficient of Variation (CV)

    Time frame: Baseline, Week 4

    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%

  2. Percent Change of C-reactive Protein (CRP) Biomarkers

    Time frame: Baseline, Week 4

    This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%

  3. Percent Change in Concentration of Interleukin-6 (IL-6) Biomarkers

    Time frame: Baseline, Week 4

    This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%

  4. Percent Change in Concentration of Tumor Necrosis Factor-alpha (TNFα) Biomarkers

    Time frame: Baseline, Week 4

    This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Doris Duke Charitable Foundation

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2023
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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