142 Participants Needed

Air Filtration for Prediabetes

SW
JN
Overseen ByJonathan Newman
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how portable air cleaners (PACs) might benefit people with prediabetes by monitoring their blood sugar levels and inflammation markers. Participants will use either a PAC with an intact HEPA filter or one with the filter removed. The trial is for adults with prediabetes who don’t smoke and can manage basic study tasks, such as wearing a monitor and setting up the air cleaner in their bedroom. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance health outcomes for people with prediabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking antihyperglycemic or anti-inflammatory medications.

What prior data suggests that these air filtration methods are safe for prediabetes patients?

Research shows that portable air cleaners (PACs) with HEPA filters are generally safe and easy to use. Studies have found that these devices effectively reduce indoor air pollution by lowering tiny harmful particles, known as PM2.5, by about 30–74%. This reduction links to positive effects on blood pressure, indicating their safety for home use. Negative effects from using PACs are rare, making them a low-risk option for improving air quality.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how air quality might impact prediabetes, a fresh angle compared to traditional diet and exercise recommendations. Unlike typical treatments that focus on lifestyle changes or medications to manage blood sugar levels, this approach investigates whether using a Portable Air Cleaner (PAC) with a HEPA filter can improve health outcomes by reducing air pollution exposure. This trial could reveal a novel non-pharmacological method to support prediabetes management, potentially offering a simple, low-effort intervention to complement existing strategies.

What evidence suggests that using a Portable Air Cleaner (PAC) with a HEPA filter is effective for prediabetes?

This trial will compare the effects of two types of portable air cleaners (PACs) on prediabetes. Research has shown that PACs with HEPA filters, which participants in one arm of this trial will use, can effectively reduce indoor air pollution by decreasing tiny particles in the air by 50–60%. These air purifiers may also benefit heart health by lowering blood pressure in individuals with higher levels. Reducing air pollution might also help with inflammation, which plays a role in prediabetes. This suggests that using a PAC with a HEPA filter could help control blood sugar and reduce inflammation in people with prediabetes. Meanwhile, participants in another arm will use a PAC with the HEPA filter removed to serve as a sham comparator.12567

Who Is on the Research Team?

JN

Jonathan Newman

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

Adults over 18 with prediabetes who speak English or Spanish, can visit the clinic for blood draws, and won't sleep away from their primary bedroom for more than a week during the study. Non-smokers only, without major dietary changes recently or diabetes medications. They must be able to lift a 20 lb air filter.

Inclusion Criteria

I can wear a continuous glucose monitor for two weeks at a time.
Participant can understand study procedures and give informed consent
I can do phone or video calls for setting up medical equipment at home.
See 6 more

Exclusion Criteria

I have not had COVID-19 in the last 30 days.
I am currently taking medication for inflammation.
I have a history of heart or blood vessel disease, including stroke or TIA.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use portable air cleaners (PACs) with or without HEPA filters for 4 weeks

4 weeks

Follow-up

Participants are monitored for changes in glycemic variability and biomarker concentrations after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Portable Air Cleaner (PAC) with HEPA filter intact
  • Portable Air Cleaner (PAC) with HEPA filter removed
Trial Overview The trial is testing if portable air cleaners (PACs) affect blood sugar levels and inflammation markers in people with prediabetes. One group uses PACs with HEPA filters; another uses PACs without filters as a control to compare results.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Portable Air Cleaner (PAC) FiltrationExperimental Treatment1 Intervention
Group II: Sham Portable Air Cleaner (PAC) FiltrationPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Doris Duke Charitable Foundation

Collaborator

Trials
65
Recruited
264,000+

Published Research Related to This Trial

In a study involving 225 children aged 6 to 12 with asthma exposed to secondhand smoke, the use of HEPA air cleaners resulted in 42 fewer unscheduled asthma visits, indicating a significant reduction in asthma-related emergencies (P = .043).
The intervention group experienced a 25% reduction in airborne particles, while the control group only saw a 5% reduction, suggesting that HEPA air cleaners effectively lower harmful particulate levels, although no significant differences were found in reported asthma symptoms or other biomarkers.
Effects of HEPA air cleaners on unscheduled asthma visits and asthma symptoms for children exposed to secondhand tobacco smoke.Lanphear, BP., Hornung, RW., Khoury, J., et al.[2021]
The RAPIDS study demonstrated that high-efficiency particulate arrestance (HEPA) filters significantly reduce indoor PM2.5 concentrations by 60% and personal PM2.5 exposures by 53% among senior citizens in Detroit, indicating their effectiveness in improving air quality and potentially cardiovascular health.
Low-efficiency (HEPA-type) filters also provided benefits, reducing indoor PM2.5 concentrations by 52% and personal exposures by 31%, suggesting that even less efficient filters can contribute to lowering harmful air pollution levels indoors.
Reduction of personal PM2.5 exposure via indoor air filtration systems in Detroit: an intervention study.Maestas, MM., Brook, RD., Ziemba, RA., et al.[2021]
A pediatric patient with diabetic ketoacidosis (DKA) was diagnosed with pneumomediastinum and a small pneumothorax, highlighting a potential complication that may be overlooked in similar cases.
The study suggests that pneumomediastinum could be more common in DKA patients than previously recognized, as its symptoms can mimic those of DKA, indicating the need for careful monitoring in these patients.
Spontaneous pneumomediastinum in a patient with diabetic ketoacidosis: a potentially hidden complication.Weathers, LS., Brooks, WG., DeClue, TJ.[2019]

Citations

An updated systematic review and meta-analysis on ...A growing number of studies have reported a beneficial effect of portable air cleaners (PACs) on systolic and diastolic BP; SBP and DBP.
Air Purifiers May Reduce Heart Risks for People Exposed ...Researchers found that participants with elevated SBP (>120 mmHg) experienced an average 2.8 mmHg reduction in SBP after one month of HEPA ...
Portable Air Cleaners Reduce Home Particulate MatterPACs equipped with filters are generally inexpensive, practical, and known to reduce indoor PM2.5 levels by typically 50–60% in experimental interventions, ...
Air Filtration for PrediabetesPortable HEPA air cleaners significantly reduce indoor PM2.5 levels, with an average decrease from 33.5 µg/m3 to 17.2 µg/m3, demonstrating their effectiveness ...
HEPA Air Filtration Trial: Reduce Cardiovascular RiskThis study has the potential to shed light on the value of using portable air filtration in homes close to highways to reduce exposure to TRAP and whether doing ...
Evaluating portable air cleaner effectiveness in residential ...Results: Depending on the house, the use of HEPA cleaners resulted in a reduction in indoor PM2.5 concentrations of 30–74%. Conclusions: HEPA ...
Real-World Effectiveness of Portable Air Cleaners in ...PACs equipped with filters are generally inexpensive, practical, and known to reduce indoor PM2.5 levels by typically 50–60% in experimental interventions, ...
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