The Impact of Fitness on Vascular Dysfunction in Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- arterial vascular stiffness
研究概览
简要总结
The principal hypothesis of this study is that the micro and macro vasculature of young diabetes mellitus type 1 (DM1) patients is particularly susceptible to atherogenic factors which cause vascular dysfunction at multiple levels of the arterial vasculature and that this dysfunction is demonstrable using state-of-the-art ultrasound methods. The investigators further hypothesize that interventions, such as exercise, that are readily integrated into the daily life of individuals with DM1 can mitigate or reverse these early vascular changes and thereby diminish the otherwise predictable longer-term development of cardiovascular disease (CVD) in type 1 DM
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •You may be eligible if you are:
- •Male or female, 12-18 years of age
- •Healthy, no chronic illness other than DM1
- •No medications that would affect the blood vessels
- •Non-smoker
- •Normal height and weight
- •Requirements for both groups (study 1)
- •Two outpatient visits lasting ~1 to 1 ½ hours
- •1 outpatient admission lasting ~ 10 hrs
- •Most visits require blood draws Requirements for second part of study for DM1 group (study 2)
- •Two additional outpatient visits (one requires blood draw)
- •12 weeks of an exercise program (5 days per week, 3 of them here at UVA)
- •Maintain healthy diet for those 12 weeks-you will have diet instruction
- •Repeat outpatient admission as described above
排除标准
- •under 12 or over 18 years of age
- •medication that could affect the blood vessels
- •above average BMI
- •chronic illness other than DM1
研究组 & 干预措施
exercise training
12 weeks of exercise treatment/program for DM1 subjects
干预措施: Definity microbubbles (Drug)
结局指标
主要结局
arterial vascular stiffness
时间窗: 2 years
Arterial Stiffness will be measured as follows: 1. Pulse wave velocity (m/sec) 2. Augmentation index ( %)
次要结局
- nitric oxide dependent vasodilation(2 years)
研究者
Eugene Barrett
Eugene Barrett, MD, PhD
University of Virginia