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Cleaner Air for Lower Cardiometabolic Risk

Primary Purpose

PreDiabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PAC with HEPA filter intact
PAC with HEPA filter removed
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring Air pollution, prediabetes, inflammation, cardiovascular disease prevention, blood sugar

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Portable Air Cleaner (PAC) Filtration

Sham Portable Air Cleaner (PAC) Filtration

Arm Description

High Efficiency Particulate Air (HEPA) filter will be left intact in the PAC for 4 weeks.

High Efficiency Particulate Air (HEPA) filter will be removed from the PAC for 4 weeks.

Outcomes

Primary Outcome Measures

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%
Percent Change of C-reactive Protein (CRP) Biomarkers
This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%
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%
Percent Change in Concentration of Tumor Necrosis Factor-alpha (TNFα) Biomarkers
This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%

Secondary Outcome Measures

Full Information

First Posted
August 9, 2023
Last Updated
August 9, 2023
Sponsor
NYU Langone Health
Collaborators
Doris Duke Charitable Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05994937
Brief Title
Cleaner Air for Lower Cardiometabolic Risk
Official Title
Glycemic and Cardiometabolic Biomarker Improvements Associated With Reduction in Air Pollution Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
July 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Doris Duke Charitable Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
Keywords
Air pollution, prediabetes, inflammation, cardiovascular disease prevention, blood sugar

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Portable Air Cleaner (PAC) Filtration
Arm Type
Experimental
Arm Description
High Efficiency Particulate Air (HEPA) filter will be left intact in the PAC for 4 weeks.
Arm Title
Sham Portable Air Cleaner (PAC) Filtration
Arm Type
Sham Comparator
Arm Description
High Efficiency Particulate Air (HEPA) filter will be removed from the PAC for 4 weeks.
Intervention Type
Device
Intervention Name(s)
PAC with HEPA filter intact
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PAC with HEPA filter removed
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Change in A Continuous Glucose Monitor (CGM) Coefficient of Variation (CV)
Description
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%
Time Frame
Baseline, Week 4
Title
Percent Change of C-reactive Protein (CRP) Biomarkers
Description
This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%
Time Frame
Baseline, Week 4
Title
Percent Change in Concentration of Interleukin-6 (IL-6) Biomarkers
Description
This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%
Time Frame
Baseline, Week 4
Title
Percent Change in Concentration of Tumor Necrosis Factor-alpha (TNFα) Biomarkers
Description
This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100%
Time Frame
Baseline, Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharine Wittkopp
Phone
646-501-8121
Email
Sharine.Wittkopp@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Newman
Phone
212-263-9393
Email
Jonathan.Newman@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Newman
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Sharine.Wittkopp@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Sharine.Wittkopp@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

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Cleaner Air for Lower Cardiometabolic Risk

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