Cleaner Air for Lower Cardiometabolic Risk (NCT05994937) | Clinical Trial Compass
CompletedNot Applicable
Cleaner Air for Lower Cardiometabolic Risk
United States150 participantsStarted 2023-12-26
Plain-language summary
The purpose of this interventional sham-controlled pilot study is to study the effects of using portable air cleaners (PACs) in outpatient adults with prediabetes. The primary aims are to determine the effect PAC's have on glycemic variability and the concentrations of circulating biomarkers of inflammation.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant is ≥18 years old
* Participant and members of household are reported to be non-smokers (defined as no household members are currently known to smoke cigarettes or use other tobacco products including e-cigarettes)
* Participant is to understand/speak English or Spanish
* Participant can understand study procedures and give informed consent
* Participant has prediabetes, defined as the absence of diabetes and any of the following: fasting plasma glucose 100-125 mg/dL, 2 hour plasma glucose of 140-199 mg/dL after 75 g oral glucose tolerance test, or A1c 5.7- 6.4%.
* Able to wear CGM for 2 two-week periods
* Able to participate in telephone or video conference for home equipment setup if needed
* Able to visit clinic for blood draws before and after the study period
* Do not intend to sleep anywhere outside of primary bedroom for more than 48 consecutive hours or a total of 7 days during the study period.
* Ability to lift, or access to assistance with lifting, 20 lb to set up air filter appliance in bedroom.
* Have not undergone major dietary change (such as change from usual diet to intermittent fasting or caloric restriction) in the past 2 weeks, and do not intend to during the study period
Exclusion Criteria:
* Participants who have diagnosed diabetes, or take antihyperglycemic medications
* Participants with known atherosclerotic disease: coronary artery disease, peripheral artery disease or history of cerebrovascular disease (stroke or …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change in A Continuous Glucose Monitor (CGM) Coefficient of Variation (CV)
Timeframe: Baseline, Week 4
2
Percent Change of C-reactive Protein (CRP) Biomarkers
Timeframe: Baseline, Week 4
3
Percent Change in Concentration of Interleukin-6 (IL-6) Biomarkers
Timeframe: Baseline, Week 4
4
Percent Change in Concentration of Tumor Necrosis Factor-alpha (TNFα) Biomarkers