Cleaner Air for Lower Cardiometabolic Risk

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

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.

Study Overview

• Status: Completed
• Conditions: PreDiabetes
• Intervention / Treatment: Device: PAC with HEPA filter intact; Device: PAC with HEPA filter removed

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Portable Air Cleaner (PAC) Filtration; High Efficiency Particulate Air (HEPA) filter will be left intact in the PAC for 4 weeks.	Device: 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.
Sham Comparator: Sham Portable Air Cleaner (PAC) Filtration; High Efficiency Particulate Air (HEPA) filter will be removed from the PAC for 4 weeks.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Doris Duke Charitable Foundation
• Investigators: Principal Investigator: Jonathan Newman, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2023
• Primary Completion (Actual): March 16, 2026
• Study Completion (Actual): April 22, 2026

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: inflammation; Air pollution; prediabetes; blood sugar; cardiovascular disease prevention
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Inflammation; Prediabetic State
• Other Study ID Numbers: 23-00755

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Sharine.Wittkopp@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Sharine.Wittkopp@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes