Clinical trial NCT05718245: HEPA, PM2.5, and Cardiometabolic Health
Official title: Using Indoor Air Filtration to Reduce PM2.5 Cardiometabolic Effects in At-risk Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Air Pollution
Cardiometabolic Health
Keywords: Air pollution
Particulate matter
Air purifier
HEPA filter
Cardiometabolic health
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2023-02-08
Enrollment: 52
Sex: ALL
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in HOMA-IR
timeFrame: At the baseline and immediately after each of the 6-month interventions
measure: Change in HbA1c
timeFrame: At the baseline and immediately after each of the 6-month interventions
Secondary outcomes:
measure: Change in fasting glucose
timeFrame: At the baseline and immediately after each of the 6-month interventions
measure: Change in fasting insulin
timeFrame: At the baseline and immediately after each of the 6-month interventions
measure: Changes in lipid profiles
timeFrame: At the baseline and immediately after each of the 6-month interventions
measure: Change in blood pressure
timeFrame: At the baseline and immediately after each of the 6-month interventions
measure: Change in continuously monitored glucose level
timeFrame: At the baseline and immediately after 3 months of intervention
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck School of Medicine, University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Zhanghua Chen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Junfeng Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: