Cleaner Air for Lower Cardiometabolic Risk

NCT ID: NCT05994937

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-26

Study Completion Date

2026-02-28

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.

Detailed Description

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Conditions

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PreDiabetes

Keywords

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Air pollution prediabetes inflammation cardiovascular disease prevention blood sugar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Active Portable Air Cleaner (PAC) Filtration

High Efficiency Particulate Air (HEPA) filter will be left intact in the PAC for 4 weeks.

Group Type EXPERIMENTAL

PAC with HEPA filter intact

Intervention Type 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.

Sham Portable Air Cleaner (PAC) Filtration

High Efficiency Particulate Air (HEPA) filter will be removed from the PAC for 4 weeks.

Group Type SHAM_COMPARATOR

PAC with HEPA filter removed

Intervention Type 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.

Interventions

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PAC 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.

Intervention Type DEVICE

PAC 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.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Doris Duke Charitable Foundation

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Newman

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Medical Center

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sharine Wittkopp

Role: CONTACT

Phone: 646-501-8121

Email: [email protected]

Jonathan Newman

Role: CONTACT

Phone: 212-263-9393

Email: [email protected]

Other Identifiers

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23-00755

Identifier Type: -

Identifier Source: org_study_id