Using air cleaners to reduce cardiometabolic risk in prediabetes
Glycemic and Cardiometabolic Biomarker Improvements Associated With Reduction in Air Pollution Exposure
This study is testing whether using portable air cleaners can help adults with prediabetes lower their blood sugar levels and reduce inflammation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05994937 on ClinicalTrials.gov |
What this trial studies
This interventional pilot study investigates the effects of portable air cleaners (PACs) on glycemic variability and inflammation biomarkers in adults with prediabetes. Participants will be assigned to use either a PAC with a HEPA filter or a sham device without the filter. The study aims to assess whether cleaner air can positively influence blood sugar levels and reduce inflammation, which are critical factors in preventing cardiovascular diseases. Participants will be monitored through continuous glucose monitoring and blood tests before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of prediabetes and non-smoking household members.
Not a fit: Patients with established diabetes or those who smoke may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new strategies for managing prediabetes and reducing the risk of cardiovascular diseases through environmental interventions.
How similar studies have performed: While the specific approach of using PACs for prediabetes is novel, related studies have shown that reducing air pollution can have health benefits.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- NYU Langone Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan Newman — NYU Langone Health
- Study coordinator: Sharine Wittkopp
- Email: Sharine.Wittkopp@nyulangone.org
- Phone: 646-501-8121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.