HEPA, PM2.5, and Cardiometabolic Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-84
SponsorUniversity of Southern California
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Crossover
Treatments tested in this trial
HEPA filter
DeviceHEPA filters with the capacity to reduce PM2.5 levels
Sham filter
Devicesham filters without the capacity to reduce PM2.5 levels
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: HEPA first and shamExperimental treatment 2 interventions
Group B: Sham first and HEPASham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change in HOMA-IR
Difference between baseline and HOMA-IR measured after 6-month intervention
Time frame
At the baseline and immediately after each of the 6-month interventions2
Change in HbA1c
Difference between baseline and HOMA-IR measured after 6-month intervention
Time frame
At the baseline and immediately after each of the 6-month interventionsSecondary outcomes
1
Change in fasting glucose
Difference between baseline and fasting glucose measured after 6-month intervention
Time frame
At the baseline and immediately after each of the 6-month interventions2
Change in fasting insulin
Difference between baseline and fasting insulin measured after 6-month intervention
Time frame
At the baseline and immediately after each of the 6-month interventions3
Changes in lipid profiles
Differences between baseline and LDL, HDL, VLDL, triglycerides, and total cholesterol levels measured after 6-month intervention
Time frame
At the baseline and immediately after each of the 6-month interventions4
Change in blood pressure
Differences between baseline and systolic and diastolic blood pressure measured after 6-month intervention
Time frame
At the baseline and immediately after each of the 6-month interventionsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Southern California
Lead sponsor
Duke University
Collaborator
Source ClinicalTrials.gov