The goal of this randomized, double-blind, crossover trial is to test the hypothesis that a longer-term indoor HEPA filtration intervention can improve cardiometabolic profiles by reducing indoor PM2.5 exposures in at-risk individuals.
This randomized, double-blind, crossover trial will recruit 52 non-diabetic adults and will investigate potential benefits of HEPA air purifiers on improving cardiometabolic profiles. Participants will be contacted and recruited to the study based on inclusion and exclusion criteria. After consenting, participants will be block randomized to HEPA and control groups for 6-month interventions by sex. After 6-month wash-out period, participants will be switched to the other arm of the intervention. During the trial, project specialists will complete a series of home visits before and after each intervention session to set up air purifiers and indoor and outdoor air pollution monitors, as well as conduct interview to collect questionnaire data, measure body weight and blood pressure, and collect biospecimen. In aim 1, the researcher will assess the effect of a 6-month residential HEPA intervention on changes of type 2 diabetes-related metabolic outcomes in 52 adults. In aim 2, the researchers will examine the association between reduction in indoor PM2.5 exposure brought by the intervention and changes in metabolic outcomes adjusting for ambient PM2.5 exposure. In aim 3, the researchers will explore major pathophysiologic changes pertinent to the cardio-metabolic profile of type 2 diabetes relevance in response to the intervention and changes in PM2.5 exposure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
52
HEPA filters with the capacity to reduce PM2.5 levels
sham filters without the capacity to reduce PM2.5 levels
Keck School of Medicine, University of Southern California
Los Angeles, California, United States
RECRUITINGChange in HOMA-IR
Difference between baseline and HOMA-IR measured after 6-month intervention
Time frame: At the baseline and immediately after each of the 6-month interventions
Change in HbA1c
Difference between baseline and HOMA-IR measured after 6-month intervention
Time frame: At the baseline and immediately after each of the 6-month interventions
Change in fasting glucose
Difference between baseline and fasting glucose measured after 6-month intervention
Time frame: At the baseline and immediately after each of the 6-month interventions
Change in fasting insulin
Difference between baseline and fasting insulin measured after 6-month intervention
Time frame: At the baseline and immediately after each of the 6-month interventions
Changes in lipid profiles
Differences between baseline and LDL, HDL, VLDL, triglycerides, and total cholesterol levels measured after 6-month intervention
Time frame: At the baseline and immediately after each of the 6-month interventions
Change in blood pressure
Differences between baseline and systolic and diastolic blood pressure measured after 6-month intervention
Time frame: At the baseline and immediately after each of the 6-month interventions
Change in continuously monitored glucose level
Difference in continuously measured glucose measured using Abbott FreeStyle Libre 2 Pro Continuous Glucose Monitor (CGM) for 2 weeks between baseline and after intervention.
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Time frame: At the baseline and immediately after 3 months of intervention