HEPA, PM2.5, and Cardiometabolic Health

Air Pollution Clinical Trial

Official title:

Using Indoor Air Filtration to Reduce PM2.5 Cardiometabolic Effects in At-risk Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05718245
• Other study ID #: UL2_Study
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: February 2024
• Source: University of Southern California
• Contact: Zhanghua Chen, PhD
• Phone: 323-442-2109
• Email: zhanghuc[@]usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 84 Years

Eligibility

Inclusion Criteria:

• Age between 65 and 84 years old;
• Nonsmoker for at least 1 year;
• History of BMI = 25 kg/m2 in the past based on EMR information;
• Either an English or Spanish speaker;
• Live in the Los Angeles County.

Exclusion Criteria:

• History of diabetes (both type 1 and type 2) or degenerative disease of the nervous system (Alzheimer's disease or dementia);
• Currently have active cancer treatment;
• The residential house has already had HEPA filters;
• Participants will move out of the current house in the next 2 years;
• Participants will spend more than one month living outside the primary home;
• Have any health conditions that prohibit collecting health and covariate data and biospecimen;
• The residential houses are not feasible for setting up air purifiers and air pollutants monitors;
• Have high blood glucose from finger stick test (> 200 mg/dL).

Related Conditions & MeSH terms

• Air Pollution
• Cardiometabolic Health

Intervention

Device:
• HEPA filter
HEPA filters with the capacity to reduce PM2.5 levels
• Sham filter
sham filters without the capacity to reduce PM2.5 levels

Locations

Country	Name	City	State
United States	Keck School of Medicine, University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Change in fasting insulin	Difference between baseline and fasting insulin measured after 6-month intervention	At the baseline and immediately after each of the 6-month interventions
Secondary	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
Secondary	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
Secondary	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