Effect of a Dual ET(Endothelin)-Blocker on Exercise Induced Vascular Adaptations in Type 2 Diabetes Mellitus (T2DM)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Flow mediated dilation
研究概览
简要总结
The purpose of this study is to establish the effect of ET blockade on vascular adaptations during an 8-week exercise program in subjects with T2DM. We hypothesize that combining ET - blockade with exercise training leads to an acute increase of exercise induced blood flow when compared with exercise alone. We expect that this will lead to an optimization of vascular training effect in T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Type 2 Diabetes Mellitus (>2 years since diagnosis) OR controls
排除标准
- •<40 years of age
- •>65 years of age
- •cardiovascular disease
- •diabetes related manifest vascular complications
- •Type 1 Diabetes Mellitus
- •use of Glibenclamide
- •use of HIV drugs
- •use of calcineurin inhibitors
- •use of drugs that interfere with CYP3A4 and CYP2C19
研究组 & 干预措施
Bosentan + Exercise
2x/day 62.5 mg Bosentan for 4 weeks alongside 3x/week supervised exercise 2x/day 125 mg Bosentan for 4 weeks alongside 3x/week supervised exercise
干预措施: Bosentan (Drug)
Bosentan + Exercise
2x/day 62.5 mg Bosentan for 4 weeks alongside 3x/week supervised exercise 2x/day 125 mg Bosentan for 4 weeks alongside 3x/week supervised exercise
干预措施: Exercise (Behavioral)
Placebo + Exercise
2x/day 62.5 mg Placebo for 4 weeks alongside 3x/week supervised exercise 2x/day 125 mg Placebo for 4 weeks alongside 3x/week supervised exercise
干预措施: Placebo (Drug)
Placebo + Exercise
2x/day 62.5 mg Placebo for 4 weeks alongside 3x/week supervised exercise 2x/day 125 mg Placebo for 4 weeks alongside 3x/week supervised exercise
干预措施: Exercise (Behavioral)
Exercise
3x/week supervised exercise for 8 weeks
干预措施: Exercise (Behavioral)
结局指标
主要结局
Flow mediated dilation
时间窗: 8 weeks
次要结局
- Maximal Oxygen Uptake(8 weeks)
- Intima-Media Thickness(8 weeks)
- Conduit Artery Dilator Capacity(8 weeks)