PreDiabetes
Conditions
Keywords
Air pollution, prediabetes, inflammation, cardiovascular disease prevention, blood sugar
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.
Interventions
DEVICEPAC with HEPA filter intact
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.
DEVICEPAC with HEPA filter removed
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.
Sponsors
NYU Langone Health
Doris Duke Charitable Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Concentration of Interleukin-6 (IL-6) Biomarkers | 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 | Baseline, Week 4 | This outcome will be measured using the following equation: ((\[post-intervention\]-\[pre-intervention\]))/(\[pre-intervention\])\*100% |
| Percent Change of C-reactive Protein (CRP) Biomarkers | Baseline, Week 4 | This outcome will be measured using the following equation: ((\[post-intervention\]-\[pre-intervention\]))/(\[pre-intervention\])\*100% |
| Percent Change in A Continuous Glucose Monitor (CGM) Coefficient of Variation (CV) | 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% |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJonathan Newman
NYU Langone Health
Outcome results
None listed