Sex Differences in the effecTs of brEaking uP Sedentary Behavior on vascUlar Function in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- iAUC of SBP
研究概览
简要总结
Type 2 diabetes (T2D) confers a high risk of cardiovascular disease (CVD), particularly among older adults who tend to be physically inactive. Prolonged sedentary behavior (SB) has been shown to negatively influence markers of cardiovascular risk (e.g., blood glucose, blood pressure), even among individuals who are physically active. Most studies that have examined the effects of breaking up SB have focused on young healthy males and prioritized glycemic outcomes. Additionally, sex differences in these outcomes have not been adequately examined. The present study will address these gaps. This 3-arm crossover randomized controlled trial will compare the effects of 3 SB conditions on markers of vascular function. The 3 conditions are: 1) 4 hours of prolonged SB, 2) 4 hours of SB broken up by 5 minutes of self-paced walking every hour, and 3) 4 hours of SB with one 20-minute bout of self-paced walking. In addition to examining the overall effects of each condition, sex differences in physiological responses will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥60 years
- •Postmenopausal (females only, ≥12 months without a menstrual period)
- •Type 2 diabetes (hemoglobin A1c ≥6.5% and/or previous diagnosis of type 2 diabetes)
- •≥6 hours/day sedentary (assessed via IPAQ)
- •Willingness to abstain from food, caffeine, alcohol and exercise for >= 24 hours, and tobacco/smoking for ≥12 hours prior to each intervention visit
- •Ability to speak and read English
排除标准
- •Type 1 diabetes
- •Uncontrolled hypertension (resting systolic ≥160 or diastolic ≥110 mmHg)
- •Initiation of hormone therapy or change in hormone therapy dose/frequency/route of administration in the previous 3 months
- •Renal dialysis
- •History of deep vein thrombosis (DVT)
- •Evidence of cognitive impairment that could impact ability to consent and/or participation (Mini-Cog score <3)
- •Achieving physical activity guidelines (≥150 minutes of MVPA/week, assessed via IPAQ))
- •Physical impairment or disability that interferes with ability to engage in PA (e.g., severe osteoarthritis, lower extremity amputation [other than toe(s)/partial foot], use of a walker or wheelchair, etc.),
- •Unstable medical/psychiatric condition that could impact study participation
结局指标
主要结局
iAUC of SBP
时间窗: 90 days
Net incremental area under the curve (iAUC) of systolic blood pressure (SBP)
次要结局
- Net iAUC of DBP(90 days)
- Net iAUC of HR(90 days)
- Net iAUC of of MAP(90 days)