健身和盐皮质激素受体阻滞剂对成人 1 型糖尿病患者血管功能障碍的影响 (EJB048)
2019年12月17日 更新者：Eugene Barrett、University of Virginia
在此协议中，将在基线、12 周的 MCR 阻断或 12 周的运动后以及在另外 12 周的 MCR 阻断、运动或两种干预措施的组合后再次研究 60 名患有 DM1 的受试者。 研究人员将评估管道功能（脉搏波速度-PWV、血流介导的扩张-FMD 和增强指数-AI）、阻力（缺血后流速-PIFV）以及心脏和骨骼肌微血管（造影增强超声-CEU）正常血糖胰岛素钳夹前后 2 小时的血管。
我们假设，与健康对照组相比，DM1 在整个动脉血管系统中的基线和胰岛素反应性血管功能均受损，并且运动训练和/或盐皮质激素受体 (MCR) 阻断将改善基线和胰岛素反应性泛动脉功能。
研究概览
详细说明
使用非侵入性方法，几项小型研究证明了导管动脉僵硬，其他小型研究报告了糖尿病 (DM1) 受试者的肱动脉一氧化氮 (NO) 释放受损。 尚未在 DM1 中系统地研究血管胰岛素作用（以胰岛素诱导的 NO 介导的导管、阻力或微血管血管舒张为特征）。 研究人员假设，与健康对照组相比，整个动脉血管系统的基线和胰岛素反应性血管功能均因 DM1 而受损，运动训练和/或盐皮质激素受体 (MCR) 阻断将改善基线和胰岛素反应性全动脉功能.
在此协议中，将在基线、12 周的 MCR 阻断或 12 周的运动后以及在另外 12 周的 MCR 阻断、运动或两种干预措施的组合后再次研究 60 名患有 DM1 的受试者。 研究人员将评估导管功能（脉搏波速度-PWV、血流介导的扩张-FMD 和增强指数-AI）、阻力（缺血后流速-PIFV）以及心脏和骨骼肌微血管（造影增强超声-CEU）血管正常血糖胰岛素钳夹前后 2 小时。
这项工作将：a) 确定血管硬度和 NO 作用指数是否在 DM1 的整个动脉树中受损； b) 确定健康、MCR 阻断或联合改善血管功能的影响； c) 为可能改善 DM1 血管健康的干预措施的早期概念验证测试引入合理范例。 虽然在拟议的研究中测量了多个终点，但研究人员指定了一个主要导管终点（增强指数）和一个主要微血管终点（CEU 微血管血容量）；这些研究以这些措施为基础。 研究人员认为，他们的实验室在提供这些基本信息方面所展示的科学专业知识方面处于独特的地位。
这里提出的研究将是第一个评估是否：1）包括心肌微血管功能在内的基础泛动脉功能是否受到 DM1 的不利影响； 2) DM1 中的血管胰岛素反应性受损，如在 DM2 中所见 3) 运动训练或 MCR 阻断单独或组合有利地影响基础状态或对胰岛素反应的 DM1 中的血管僵硬或 NO 诱导的松弛。 这种非侵入性血管分析提供了泛动脉健康的功能性“生物标志物”。 因此，它可能有助于在小规模研究中评估特定短期干预对关键血管功能的影响（例如 MCR 阻断剂、他汀类药物、GLP-1R 激动剂），从而为后续更大规模的临床结果试验选择候选疗法提供了依据。 此外，对全动脉功能的非侵入性评估可以提供一个平台来识别患者，以便将其作为护理计划的一部分进行早期或更强化的治疗干预。
研究类型
介入性
注册 (实际的)
32
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Virginia
-
Charlottesville、Virginia、美国、22906
- University of Virginia
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 50年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
纳入标准：
- 年龄 18-50 岁
- 体重指数≤30
- 除了与 DM1 一致的值外，没有具有临床意义的实验室值
- 受试者将使用胰岛素至少 5 年且 HbA1c <9
排除标准：
- 目前或过去 6 个月内吸烟
- 影响脉管系统的药物（ACE 或 ARB 除外，尽管他们需要在研究前停用这些药物 2 周）。
- 升高的低密度脂蛋白胆固醇 > 160
- 血压 <100/60 或 >160/90
- 脉搏血氧仪 <90%
- 怀孕或哺乳
- 心血管病史、脑血管病史、周围血管病史、肝病史
- 存在心内或肺内分流（我们将在体格检查期间通过听诊来筛查）。
- 已知对 perflutren 过敏（包含在 Definity 中）
- 血清钾≥5.0
- 糖化血红蛋白≥9
- 视网膜病变
- 过去一年内发生酮症酸中毒。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘
- 屏蔽：没有任何
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：独自运动
24周的运动治疗
|
24周的运动治疗
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实验性的：单独使用螺内酯
螺内酯治疗 24 周
|
螺内酯 24 周
|
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实验性的：运动+螺内酯
24周运动+螺内酯治疗
|
24周的运动治疗
螺内酯 24 周
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
增强指数-相对于基线的变化
大体时间：24周
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在基线和 24 周时测量
|
24周
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
流量介导的扩张-相对于基线的变化
大体时间：24周
|
在基线和 24 周时测量
|
24周
|
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脉搏波速度-相对于基线的变化
大体时间：24周
|
在基线和 24 周时测量
|
24周
|
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缺血后血流速度-相对于基线的变化
大体时间：24周
|
在基线和 24 周时测量
|
24周
|
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胰岛素敏感性-相对于基线的变化
大体时间：24周
|
在基线和 24 周时通过正常血糖胰岛素钳夹测量
|
24周
|
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微血管血容量-相对于基线的变化
大体时间：24周
|
在基线和 24 周时测量
|
24周
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Eugene Barrett, MD, PhD、University of Virginia, Dept of Endocrinology
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年8月1日
初级完成 (实际的)
2019年5月22日
研究完成 (实际的)
2019年5月22日
研究注册日期
首次提交
2017年5月23日
首先提交符合 QC 标准的
2017年5月30日
首次发布 (实际的)
2017年6月2日
研究记录更新
最后更新发布 (实际的)
2019年12月18日
上次提交的符合 QC 标准的更新
2019年12月17日
最后验证
2019年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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