Air Filtration for Prediabetes

Overseen By Jonathan Newman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Antihyperglycemics, Anti-inflammatories

Disqualifiers: Diabetes, Atherosclerotic disease, Inflammatory conditions, Pregnancy, Covid-19, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

142 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Portable Air Cleaner (PAC) with HEPA filter for prediabetes?

While there is no direct evidence for prediabetes, studies show that Portable Air Cleaners (PAC) with HEPA filters are effective in removing airborne particles and viruses like SARS-CoV-2, which can improve indoor air quality and potentially benefit overall health. ^{1 2 3 4 5}

Is using a HEPA air cleaner safe for humans?

Research on HEPA air cleaners, often used to improve air quality by reducing particles like PM2.5 (tiny air pollutants) and viruses, shows they are generally safe for humans. Studies have focused on their effectiveness in reducing asthma symptoms and exposure to harmful particles, without reporting any safety concerns for users. ^{2 3 6 7 8}

How does the air filtration treatment for prediabetes differ from other treatments?

The air filtration treatment for prediabetes is unique because it uses a portable air cleaner with a HEPA filter to potentially improve air quality, which is different from traditional treatments that focus on diet, exercise, or medication. This approach is novel as it targets environmental factors that may influence prediabetes, rather than directly altering blood sugar levels. ^{9 10 11 12 13}

Research Team

Jonathan Newman

Principal Investigator

NYU Langone Health

Eligibility Criteria

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 understand and speak English or Spanish.

I can wear a continuous glucose monitor for two weeks at a time.

Participant can understand study procedures and give informed consent

Exclusion Criteria

I am currently taking medication for inflammation.

I have not had COVID-19 in the last 30 days.

I have a history of heart or blood vessel disease, including stroke or TIA.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Active Portable Air Cleaner (PAC) Filtration Experimental Treatment 1 Intervention

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

Group II: Sham Portable Air Cleaner (PAC) Filtration Placebo Group 1 Intervention

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

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+

Findings from Research

In a study involving 29 air and surface samples from 9 households with COVID-19 patients, 100% of air samples and 75% of surface samples tested positive for SARS-CoV-2 before using Portable Air Cleaners (PAC).

After using PAC with HEPA filters, 80% of samples tested negative for the virus, demonstrating the effectiveness of these devices in reducing SARS-CoV-2 contamination in poorly ventilated indoor environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are the Portable Air Cleaners (PAC) really effective to terminate airborne SARS-CoV-2? Rodríguez, M., Palop, ML., Seseña, S., et al.[2022]

Portable 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 in improving indoor air quality.

The study found that the most effective reduction in PM2.5 levels occurred with medium-flow setting machines, highlighting the importance of machine type, airflow speed, and window ventilation in optimizing air cleaner performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of HEPA Air Cleaner on Improving Indoor Particulate Matter 2.5 Concentration. Chen, CF., Hsu, CH., Chang, YJ., et al.[2023]

A study demonstrated that HEPA filters can effectively remove airborne SARS-CoV-2, achieving capture ratios of 85.38%, 96.03%, and over 99.97% at different ventilation volumes, indicating their potential for infection control in indoor environments.

The performance of HEPA filters coated with an antiviral agent was found to be comparable to that of conventional HEPA filters, suggesting that both types are effective in reducing the spread of COVID-19 in the air.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of HEPA Filters at Removing Infectious SARS-CoV-2 from the Air. Ueki, H., Ujie, M., Komori, Y., et al.[2022]

Electret filters (EE) initially remove particles more effectively than high-efficiency filters (HE) in the 0.3-3.5 μm size range, but their efficiency decreases significantly over time, dropping to 60% after processing 25 × 10⁴ m³/m² of air.

Portable air cleaners (PAC) with a combination of pre-filters and high-efficiency filters (PR&HE) achieved the highest single-pass efficiency for PM1.0 at 88.6%, indicating that filter combinations can enhance particle removal but may also reduce airflow rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental Study on Ultrafine Particle Removal Performance of Portable Air Cleaners with Different Filters in an Office Room. Ma, H., Shen, H., Shui, T., et al.[2018]

Stand-alone HEPA air cleaners can effectively reduce indoor fine particle concentrations by up to 90% during shelter-in-place scenarios following outdoor bioaerosol releases, based on a model analysis of various conditions.

The effectiveness of these air cleaners is influenced by factors such as the number of units used, HVAC system operation, and particle size, but they remain a viable option for improving indoor air quality in residential settings during potential bioterrorism events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of stand alone air cleaners for shelter-in-place. Ward, M., Siegel, JA., Corsi, RL.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 71 households with children aged 6-12 who have asthma, the use of portable HEPA air cleaners significantly reduced PM2.5 levels by 60% in sleeping areas and 42% in living areas after one year, compared to control homes.

Despite the reduction in PM2.5, the HEPA air cleaners did not lead to a significant decrease in ammonia (NH3) levels, indicating that while they are effective for particulate matter, they may not address all air quality concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of portable HEPA air cleaners on reducing indoor PM2.5 and NH3 in an agricultural cohort of children with asthma: A randomized intervention trial. Riederer, AM., Krenz, JE., Tchong-French, MI., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous pneumomediastinum in a patient with diabetic ketoacidosis: a potentially hidden complication. Weathers, LS., Brooks, WG., DeClue, TJ.[2019]

Diabetes significantly increases the risk of hospitalization due to pneumonia, with an adjusted relative risk of 1.26 for diabetic patients compared to those without diabetes, based on a study of over 34,000 pneumonia cases.

Poor glycemic control, indicated by higher A1C levels, further elevates this risk, with a relative risk of 1.60 for diabetic patients with A1C levels of 9% or higher, highlighting the importance of managing blood sugar levels to reduce pneumonia hospitalization risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes, glycemic control, and risk of hospitalization with pneumonia: a population-based case-control study. Kornum, JB., Thomsen, RW., Riis, A., et al.[2021]

In a study of 1961 adults with community-acquired pneumonia, 5.0% had undiagnosed diabetes mellitus and 37.5% had prediabetes, highlighting a significant prevalence of these conditions in pneumonia patients.

Patients with undiagnosed diabetes mellitus had a notably higher 180-day mortality rate (12.1%) compared to those without diabetes (3.8%), indicating a serious risk associated with undiagnosed diabetes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Undiagnosed Diabetes Mellitus in Community-Acquired Pneumonia: A Prospective Cohort Study. Jensen, AV., Faurholt-Jepsen, D., Egelund, GB., et al.[2022]

A 39-year-old male developed high altitude pulmonary edema (HAPE) after returning to a high altitude of 3500 m, which was complicated by undiagnosed Type 2 diabetes leading to diabetic ketoacidosis (DKA).

Despite initial treatment for HAPE, the patient's condition did not improve until DKA was also addressed, highlighting the importance of recognizing and managing multiple concurrent conditions in high-altitude illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetic ketoacidosis in an undiagnosed diabetic precipitated by high altitude pulmonary edema. Ahmad, FM.[2006]

A young woman with type 1 diabetes experienced severe diabetic ketoacidosis, which led to the accidental discovery of surgical emphysema, pneumomediastinum, and bilateral pneumothoraces during her hospital admission.

The surgical emphysema was likely caused by her labored breathing during the ketoacidosis, but no treatment was required for these conditions, indicating a potentially benign course in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Asymptomatic mediastinal and neck emphysema after Kussmaul's respiration and purging]. Søe-Jensen, P.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Are the Portable Air Cleaners (PAC) really effective to terminate airborne SARS-CoV-2? [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of HEPA Air Cleaner on Improving Indoor Particulate Matter 2.5 Concentration. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of HEPA Filters at Removing Infectious SARS-CoV-2 from the Air. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Experimental Study on Ultrafine Particle Removal Performance of Portable Air Cleaners with Different Filters in an Office Room. [2018]

5. England pubmed.ncbi.nlm.nih.gov

The effectiveness of stand alone air cleaners for shelter-in-place. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of HEPA air cleaners on unscheduled asthma visits and asthma symptoms for children exposed to secondhand tobacco smoke. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Reduction of personal PM2.5 exposure via indoor air filtration systems in Detroit: an intervention study. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Effectiveness of portable HEPA air cleaners on reducing indoor PM2.5 and NH3 in an agricultural cohort of children with asthma: A randomized intervention trial. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Spontaneous pneumomediastinum in a patient with diabetic ketoacidosis: a potentially hidden complication. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Diabetes, glycemic control, and risk of hospitalization with pneumonia: a population-based case-control study. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Undiagnosed Diabetes Mellitus in Community-Acquired Pneumonia: A Prospective Cohort Study. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Diabetic ketoacidosis in an undiagnosed diabetic precipitated by high altitude pulmonary edema. [2006]

13. Denmark pubmed.ncbi.nlm.nih.gov

[Asymptomatic mediastinal and neck emphysema after Kussmaul's respiration and purging]. [2022]