1 型糖尿病对人类全动脉血管功能和胰岛素敏感性的影响 (EJB046)
2016年1月12日 更新者:Eugene Barrett、University of Virginia
动脉血管疾病是 1 型糖尿病患者 (DM1) 发病率和死亡率的主要原因。
代谢性胰岛素抵抗 (metIR),即使没有高血糖,也会使普通人群的 CVD 风险增加 1.5 至 3 倍。
已反复证明代谢胰岛素抵抗 (MetIR) 在患有 DM1 的成人和青少年中普遍存在。
肥胖和 DM2 中的 MetIR 伴有血管胰岛素抵抗 (vasIR),其特征是胰岛素对抵抗或微血管的血管舒张作用受损。
尚未在 DM1 中系统地研究 VasIR。
我们假设在年轻人中,DM1 会损害整个动脉血管系统的基线和胰岛素反应性血管功能。
研究概览
地位
完全的
条件
详细说明
在我们的研究中,将 20 名健康对照受试者与 20 名 DM1 患者(18-40 岁)进行比较。
我们将评估导管功能(脉搏波速度-PWV、血流介导的扩张-FMD 和增强指数-AI)、阻力(缺血后血流速度-PIFV)以及心脏和骨骼肌微血管(对比增强超声-CEU)血管正常血糖胰岛素钳夹前后 2 小时。
研究类型
观察性的
注册 (实际的)
7
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
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Virginia
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Charlottesville、Virginia、美国、22903
- University of Virginia
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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 40年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
1 型糖尿病健康对照
描述
纳入标准:
- 18-40岁
- 体重指数≤25
- 健康无慢性病(仅对照组)
- 正常筛选实验室或没有临床意义的值
- DM1 受试者将使用胰岛素至少 5 年且 HbA1c <9
排除标准:
- 患有 1 型或 2 型糖尿病的一级亲属(仅适用于对照组)
- 目前或过去 6 个月内吸烟
- 影响脉管系统的药物(DM1 受试者中的 ACE 或 ARB 除外,尽管他们需要在研究前 2 周停用这些药物)。
- 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)
对于 DM1 组:
- 糖化血红蛋白≥9
- 微量白蛋白尿
- 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
队列和干预
团体/队列 |
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1型糖尿病
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控制
正常健康对照
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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 |
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增强指数
大体时间:基线
|
血管测量
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基线
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脉搏波速度
大体时间:基线
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血管测量
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基线
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流量介导的扩张
大体时间:基线
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血管测量
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基线
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对比增强超声
大体时间:基线
|
血管测量
|
基线
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增强指数
大体时间:2小时胰岛素钳夹后
|
血管测量
|
2小时胰岛素钳夹后
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脉搏波速度
大体时间:2小时胰岛素钳夹后
|
血管测量
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2小时胰岛素钳夹后
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流量介导的扩张
大体时间:2小时胰岛素钳夹后
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血管测量
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2小时胰岛素钳夹后
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对比增强超声
大体时间:2小时胰岛素钳夹后
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血管测量
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2小时胰岛素钳夹后
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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 J. B, MD, PhD、University of Virginia
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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- Libby P, Nathan DM, Abraham K, Brunzell JD, Fradkin JE, Haffner SM, Hsueh W, Rewers M, Roberts BT, Savage PJ, Skarlatos S, Wassef M, Rabadan-Diehl C; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Report of the National Heart, Lung, and Blood Institute-National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Circulation. 2005 Jun 28;111(25):3489-93. doi: 10.1161/CIRCULATIONAHA.104.529651. No abstract available.
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- Clerk LH, Vincent MA, Barrett EJ, Lankford MF, Lindner JR. Skeletal muscle capillary responses to insulin are abnormal in late-stage diabetes and are restored by angiotensin-converting enzyme inhibition. Am J Physiol Endocrinol Metab. 2007 Dec;293(6):E1804-9. doi: 10.1152/ajpendo.00498.2007. Epub 2007 Oct 2.
- Rattigan S, Clark MG, Barrett EJ. Acute vasoconstriction-induced insulin resistance in rat muscle in vivo. Diabetes. 1999 Mar;48(3):564-9. doi: 10.2337/diabetes.48.3.564.
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- Schram MT, Chaturvedi N, Schalkwijk CG, Fuller JH, Stehouwer CD; EURODIAB Prospective Complications Study Group. Markers of inflammation are cross-sectionally associated with microvascular complications and cardiovascular disease in type 1 diabetes--the EURODIAB Prospective Complications Study. Diabetologia. 2005 Feb;48(2):370-8. doi: 10.1007/s00125-004-1628-8. Epub 2005 Feb 4.
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- Clausen P, Jacobsen P, Rossing K, Jensen JS, Parving HH, Feldt-Rasmussen B. Plasma concentrations of VCAM-1 and ICAM-1 are elevated in patients with Type 1 diabetes mellitus with microalbuminuria and overt nephropathy. Diabet Med. 2000 Sep;17(9):644-9. doi: 10.1046/j.1464-5491.2000.00347.x.
- Clark AD, Barrett EJ, Rattigan S, Wallis MG, Clark MG. Insulin stimulates laser Doppler signal by rat muscle in vivo, consistent with nutritive flow recruitment. Clin Sci (Lond). 2001 Mar;100(3):283-90.
- Llaurado G, Simo R, Villaplana M, Berlanga E, Vendrell J, Gonzalez-Clemente JM. Can augmentation index substitute aortic pulse wave velocity in the assessment of central arterial stiffness in type 1 diabetes? Acta Diabetol. 2012 Dec;49 Suppl 1:S253-7. doi: 10.1007/s00592-012-0433-y. Epub 2012 Oct 2.
- Westerbacka J, Uosukainen A, Makimattila S, Schlenzka A, Yki-Jarvinen H. Insulin-induced decrease in large artery stiffness is impaired in uncomplicated type 1 diabetes mellitus. Hypertension. 2000 May;35(5):1043-8. doi: 10.1161/01.hyp.35.5.1043.
- Llaurado G, Ceperuelo-Mallafre V, Vilardell C, Simo R, Freixenet N, Vendrell J, Gonzalez-Clemente JM. Arterial stiffness is increased in patients with type 1 diabetes without cardiovascular disease: a potential role of low-grade inflammation. Diabetes Care. 2012 May;35(5):1083-9. doi: 10.2337/dc11-1475. Epub 2012 Feb 22.
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
2014年12月1日
初级完成 (实际的)
2015年6月1日
研究完成 (实际的)
2015年6月1日
研究注册日期
首次提交
2015年7月1日
首先提交符合 QC 标准的
2015年7月2日
首次发布 (估计)
2015年7月3日
研究记录更新
最后更新发布 (估计)
2016年1月13日
上次提交的符合 QC 标准的更新
2016年1月12日
最后验证
2016年1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.
1 型糖尿病的临床试验
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