Clinical trial NCT05994937: Cleaner Air for Lower Cardiometabolic Risk
Official title: Glycemic and Cardiometabolic Biomarker Improvements Associated With Reduction in Air Pollution Exposure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PreDiabetes
Keywords: Air pollution
prediabetes
inflammation
cardiovascular disease prevention
blood sugar
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2023-08-16
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Percent Change in A Continuous Glucose Monitor (CGM) Coefficient of Variation (CV)
timeFrame: Baseline, Week 4
measure: Percent Change of C-reactive Protein (CRP) Biomarkers
timeFrame: Baseline, Week 4
measure: Percent Change in Concentration of Interleukin-6 (IL-6) Biomarkers
timeFrame: Baseline, Week 4
measure: Percent Change in Concentration of Tumor Necrosis Factor-alpha (TNFα) Biomarkers
timeFrame: Baseline, Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jonathan Newman
role: PRINCIPAL_INVESTIGATOR
References: