HEPA, PM2.5, and Cardiometabolic Health

University of Southern California

Status: Enrolling

Conditions: Cardiometabolic Health; Air Pollution

Treatments: Device: HEPA filter; Device: Sham filter

Study type: Interventional

Funder types: Other

Identifiers

NCT05718245

UL2_Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 65 to 84 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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52 participants in 2 patient groups

HEPA first and sham

Experimental group

Description:

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.

Treatment:

Device: Sham filter

Device: HEPA filter

Sham first and HEPA

Sham Comparator group

Description:

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.

Treatment:

Device: Sham filter

Device: HEPA filter