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Device
Air Filtration for Prediabetes
N/A
Recruiting
Led By Jonathan Newman
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant is to understand/speak English or Spanish
Participant has prediabetes, defined as the absence of diabetes and specific glucose level criteria
Must not have
Participants currently taking any anti-inflammatory medications or medications that target inflammatory cytokines
Participants with known atherosclerotic disease: coronary artery disease, peripheral artery disease or history of cerebrovascular disease (stroke or Transient Ischemic Attack (TIA), carotid stenosis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4
Summary
This trial studies how portable air cleaners (PACs) may help adults with prediabetes by affecting glucose levels & biomarkers of inflammation.
Who is the study for?
Adults over 18 with prediabetes who speak English or Spanish, can visit the clinic for blood draws, and won't sleep away from their primary bedroom for more than a week during the study. Non-smokers only, without major dietary changes recently or diabetes medications. They must be able to lift a 20 lb air filter.
What is being tested?
The trial is testing if portable air cleaners (PACs) affect blood sugar levels and inflammation markers in people with prediabetes. One group uses PACs with HEPA filters; another uses PACs without filters as a control to compare results.
What are the potential side effects?
Since this trial involves using air cleaners rather than medication, there are no direct side effects from drugs. However, unforeseen reactions due to environmental changes cannot be completely ruled out.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can understand and speak English or Spanish.
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I have prediabetes based on my glucose levels.
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I am 18 years old or older.
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I can lift 20 lb or have help to set up an air filter.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medication for inflammation.
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I have a history of heart or blood vessel disease, including stroke or TIA.
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I am experiencing long-term effects from COVID-19.
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I have diabetes or take medication to lower my blood sugar.
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I have a condition like arthritis, IBD, or had cancer in the last 5 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent Change in A Continuous Glucose Monitor (CGM) Coefficient of Variation (CV)
Percent Change in Concentration of Interleukin-6 (IL-6) Biomarkers
Percent Change in Concentration of Tumor Necrosis Factor-alpha (TNFα) Biomarkers
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Portable Air Cleaner (PAC) FiltrationExperimental Treatment1 Intervention
High Efficiency Particulate Air (HEPA) filter will be left intact in the PAC for 4 weeks.
Group II: Sham Portable Air Cleaner (PAC) FiltrationPlacebo Group1 Intervention
High Efficiency Particulate Air (HEPA) filter will be removed from the PAC for 4 weeks.
Find a Location
Who is running the clinical trial?
Doris Duke Charitable FoundationOTHER
64 Previous Clinical Trials
264,268 Total Patients Enrolled
NYU Langone HealthLead Sponsor
1,409 Previous Clinical Trials
855,446 Total Patients Enrolled
Jonathan NewmanPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
440 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and speak English or Spanish.I can wear a continuous glucose monitor for two weeks at a time.I am currently taking medication for inflammation.I have not had COVID-19 in the last 30 days.I can do phone or video calls for setting up medical equipment at home.I have a history of heart or blood vessel disease, including stroke or TIA.I have prediabetes based on my glucose levels.I am experiencing long-term effects from COVID-19.I am 18 years old or older.I have diabetes or take medication to lower my blood sugar.I can lift 20 lb or have help to set up an air filter.I have a condition like arthritis, IBD, or had cancer in the last 5 years.I can go to the clinic for blood tests before and after the study.You are already using HEPA filtration in your bedroom.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Portable Air Cleaner (PAC) Filtration
- Group 2: Active Portable Air Cleaner (PAC) Filtration
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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