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| Name | Class |
|---|---|
| Duke University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEPA first and sham | Experimental | This group of participants will be assigned an intervention of HEPA filters with the capacity to reduce PM2.5 levels at their residence for 6 months. After 6-month wash-out period, will be assigned to sham filters for 6 months. |
|
| Sham first and HEPA | Sham Comparator | This group of participants will be assigned an intervention of sham filters without the capacity to reduce PM2.5 levels at their residence for 6 months. After 6-month wash-out period, will be assigned to HEPA filters for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEPA filter | Device | HEPA filters with the capacity to reduce PM2.5 levels |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HOMA-IR | Difference between baseline and HOMA-IR measured after 6-month intervention | 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 | At the baseline and immediately after each of the 6-month interventions |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting glucose | Difference between baseline and fasting glucose measured after 6-month intervention | At the baseline and immediately after each of the 6-month interventions |
| Change in fasting insulin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhanghua Chen, PhD | Contact | 323-442-2109 | zhanghuc@usc.edu | |
| Junfeng Zhang, PhD | Contact | 919-681-7782 | junfeng.zhang@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Zhanghua Chen, PhD | University of Southern California | Principal Investigator |
| Junfeng Zhang, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck School of Medicine, University of Southern California | Recruiting | Los Angeles | California | 90033 | United States |
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A sham filter will be used in the control, to replace HEPA filter in the intervention group. Participants and investigators will be blinded to the intervention type, only specific investigator who will prepare air filter for intervention will be unblinded for the real air filter type.
| Sham filter | Device | sham filters without the capacity to reduce PM2.5 levels |
|
Difference between baseline and fasting insulin measured after 6-month intervention
| 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 | 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 | 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. | At the baseline and immediately after 3 months of intervention |