Glycemic and Cardiometabolic Biomarker Improvements Associated With Reduction in Air Pollution Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percent Change in A Continuous Glucose Monitor (CGM) Coefficient of Variation (CV)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active Portable Air Cleaner (PAC) Filtration
High Efficiency Particulate Air (HEPA) filter will be left intact in the PAC for 4 weeks.
干预措施: PAC with HEPA filter intact (Device)
Sham Portable Air Cleaner (PAC) Filtration
High Efficiency Particulate Air (HEPA) filter will be removed from the PAC for 4 weeks.
干预措施: PAC with HEPA filter removed (Device)
结局指标
主要结局
Percent Change in A Continuous Glucose Monitor (CGM) Coefficient of Variation (CV)
时间窗: Baseline, Week 4
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
时间窗: Baseline, Week 4
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
时间窗: Baseline, Week 4
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
时间窗: Baseline, Week 4
This outcome will be measured using the following equation: ((\[post-intervention\]-\[pre-intervention\]))/(\[pre-intervention\])\*100%
次要结局
未报告次要终点