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NCT Number: NCT05718245

HEPA, PM2.5, and Cardiometabolic Health

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.

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Key information

Age range

65 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keck School of Medicine, University of Southern California

Los Angeles, California, 90033, United States

Location status: Recruiting

Location contact

Zhanghua Chen, PhD

CONTACT

[email protected]

323-442-2109

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

HEPA Filter

Device

HEPA filters with the capacity to reduce PM2.5 levels

Sham filter

Device

sham filters without the capacity to reduce PM2.5 levels

Primary outcomes

  1. Change in HOMA-IR

    Time frame: At the baseline and immediately after each of the 6-month interventions

    Difference between baseline and HOMA-IR measured after 6-month intervention

  2. Change in HbA1c

    Time frame: At the baseline and immediately after each of the 6-month interventions

    Difference between baseline and HOMA-IR measured after 6-month intervention

Secondary outcomes

  1. Change in fasting glucose

    Time frame: At the baseline and immediately after each of the 6-month interventions

    Difference between baseline and fasting glucose measured after 6-month intervention

  2. Change in fasting insulin

    Time frame: At the baseline and immediately after each of the 6-month interventions

    Difference between baseline and fasting insulin measured after 6-month intervention

  3. Changes in lipid profiles

    Time frame: At the baseline and immediately after each of the 6-month interventions

    Differences between baseline and LDL, HDL, VLDL, triglycerides, and total cholesterol levels measured after 6-month intervention

  4. Change in blood pressure

    Time frame: At the baseline and immediately after each of the 6-month interventions

    Differences between baseline and systolic and diastolic blood pressure measured after 6-month intervention

  5. Change in continuously monitored glucose level

    Time frame: At the baseline and immediately after 3 months of intervention

    Difference in continuously measured glucose measured using Abbott FreeStyle Libre 2 Pro Continuous Glucose Monitor (CGM) for 2 weeks between baseline and after intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Junfeng Zhang, PhD

CONTACT

[email protected]

919-681-7782

Zhanghua Chen, PhD

CONTACT

[email protected]

323-442-2109

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Duke University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 8, 2023
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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