Cleaner Air for Lower Cardiometabolic Risk

NCT05994937 | Recruiting FDA Device

• 1 other identifier: 23-00755
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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 the effect PAC's have on glycemic variability and the concentrations of circulating biomarkers of inflammation.

Conditions

PreDiabetes

Keywords

Air pollution; prediabetes; inflammation; cardiovascular disease prevention; blood sugar

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Active Portable Air Cleaner (PAC) Filtration

EXPERIMENTAL

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

Device: PAC with HEPA filter intact

Sham Portable Air Cleaner (PAC) Filtration

SHAM COMPARATOR

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

Device: PAC with HEPA filter removed

Interventions

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.

Active Portable Air Cleaner (PAC) Filtration

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.

Sham Portable Air Cleaner (PAC) Filtration

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Doris Duke Charitable Foundation: collaborator

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Inflammation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Newman

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharine Wittkopp

CONTACT

646-501-8121; Sharine.Wittkopp@nyulangone.org

Jonathan Newman

CONTACT

212-263-9393; Jonathan.Newman@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: December 26, 2023
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)