RECRUITING

Cleaner Air for Lower Cardiometabolic Risk

Conditions

PreDiabetes Air pollution inflammation cardiovascular disease prevention blood sugar

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-26

Study Completion:2025-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05994937

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Sharine Wittkopp

CONTACT

646-501-8121

Sharine.Wittkopp@nyulangone.org

Jonathan Newman

CONTACT

212-263-9393

Jonathan.Newman@nyulangone.org

Principal Investigator

Jonathan Newman

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

NYU Langone Medical Center

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Jonathan Newman, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-26

Study Completion Date2025-07-30

Study Record Updates

Study Start Date2023-12-26

Study Completion Date2025-07-30

Terms related to this study

Keywords Provided by Researchers

Air pollution
prediabetes
inflammation
cardiovascular disease prevention
blood sugar

Additional Relevant MeSH Terms

PreDiabetes