Cleaner Air for Lower Cardiometabolic Risk

PreDiabetes Clinical Trial

Official title:

Glycemic and Cardiometabolic Biomarker Improvements Associated With Reduction in Air Pollution Exposure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05994937
• Other study ID #: 23-00755
• Status: Recruiting
• Phase: N/A
• Start date: December 26, 2023
• Est. completion date: July 30, 2025

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: Sharine Wittkopp
• Phone: 646-501-8121
• Email: Sharine.Wittkopp[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: July 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 Transient Ischemic Attack (TIA), carotid stenosis)
• Participants with known systemic inflammatory conditions (including but not limited to: inflammatory arthritis, vasculitides, inflammatory bowel diseases, cancer within past 5 years, Hashimoto's thyroiditis)
• Participants currently taking any anti-inflammatory medications or medications that target inflammatory cytokines
• Pregnancy: because blood glucose problems during pregnancy require intensive monitoring and lifestyle changes to protect the mother and fetus
• Participants with known or suspected Covid-19 in the prior 30 days
• Participants with post-covid sequelae (a.k.a "Long covid")
• Participants who are already utilizing HEPA filtration (PAC or within HVAC) in bedrooms

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Device:
• PAC with HEPA filter intact
A commercially available PAC with a true HEPA filter will be used. Unit will be placed in the bedroom and used continuously (24 hours/day) for a total of 4 weeks.
• PAC with HEPA filter removed
Uses the same model as the experimental PAC that is identical in appearance and sound with the HEPA filter removed . Unit will be placed in the bedroom and used continuously (24 hours/day) for a total of 4 weeks.

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Doris Duke Charitable Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in A Continuous Glucose Monitor (CGM) Coefficient of Variation (CV)	A CGM will be placed at baseline to continuously measure glucose, which will then be used to assess glycemic variability at the end of 4 weeks post-intervention. This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%	Baseline, Week 4
Primary	Percent Change of C-reactive Protein (CRP) Biomarkers	This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%	Baseline, Week 4
Primary	Percent Change in Concentration of Interleukin-6 (IL-6) Biomarkers	This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%	Baseline, Week 4
Primary	Percent Change in Concentration of Tumor Necrosis Factor-alpha (TNFa) Biomarkers	This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%	Baseline, Week 4