PreDiabetesNCT05994937
Cleaner Air for Lower Cardiometabolic Risk
A study testing PAC with HEPA filter intact and PAC with HEPA filter removed in people with PreDiabetes, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- PAC with HEPA filter intact and PAC with HEPA filter removed
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Dec 2023to 22 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
Official title: 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.
- Conditions
- PreDiabetes
- Being tested
- PAC with HEPA filter intact, PAC with HEPA filter removed
- Keywords
- Air pollution, prediabetes, inflammation, cardiovascular disease prevention, blood sugar
- Medical subject headings
- Prediabetic State, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAC with HEPA filter intactDevice
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 removedDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Portable Air Cleaner (PAC) Filtration | Experimental | High Efficiency Particulate Air (HEPA) filter will be left intact in the PAC for 4 weeks. Receives: 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. Receives: Device: PAC with HEPA filter removed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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%
Measured: 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%
Measured: 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%
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start26 Dec 2023
- Primary completion16 Mar 2026
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Jonathan Newman, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994937
- Sponsor's protocol ID
- 23-00755
- Status last verified
- May 2026
- First submitted
- 9 Aug 2023
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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
Publications
Wittkopp S, Asachi P, Kazatsker F, Barua S, Aleman JO, Gordon T, Brook RD, Thorpe LE, Newman JD. Cleaner Air for Lower Cardiometabolic Risk: protocol for a double-blind, randomized, sham-controlled trial of HEPA filtration in adults with prediabetes. Am Heart J. 2026 Aug 14:107573. doi: 10.1016/j.ahj.2026.107573. Online ahead of print.
PubMed 42600906
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic and Cardiometabolic Biomarker Improvements Associated With Reduction in Air Pollution Exposure
- ClinicalTrials.gov ID
- NCT05994937
- Acronym / sponsor ID
- 23-00755
- Conditions
- PreDiabetes
- Keywords
- Air pollution, prediabetes, inflammation, cardiovascular disease prevention, blood sugar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Study start
- 26 Dec 2023 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Portable Air Cleaner (PAC) Filtration | Experimental | Device: PAC with HEPA filter intactHigh Efficiency Particulate Air (HEPA) filter will be left intact in the PAC for 4 weeks. |
| Sham Portable Air Cleaner (PAC) Filtration | Sham comparator | Device: PAC with HEPA filter removedHigh Efficiency Particulate Air (HEPA) filter will be removed from the PAC for 4 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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%.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAC with HEPA filter intactA 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. | Device | Active Portable Air Cleaner (PAC) Filtration |
| PAC with HEPA filter removedUses 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. | Device | Sham Portable Air Cleaner (PAC) Filtration |
Primary outcome
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%
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%
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%
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%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 42600906Wittkopp S, Asachi P, Kazatsker F, Barua S, Aleman JO, Gordon T, Brook RD, Thorpe LE, Newman JD. Cleaner Air for Lower Cardiometabolic Risk: protocol for a double-blind, randomized, sham-controlled trial of HEPA filtration in adults with prediabetes. Am Heart J. 2026 Aug 14:107573. doi: 10.1016/j.ahj.2026.107573. Online ahead of print.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Newman principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAC with HEPA filter intact and PAC with HEPA filter removed in people with PreDiabetes, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in A Continuous Glucose Monitor (CGM) Coefficient of Variation (CV) (time frame: Baseline, Week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05994937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.