THE EFFECTS OF EXENATIDE TO LANTUS INSULIN ON VASCULAR FUNCTION

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项随机、非盲法的对比研究，将评估埃塞那肽对内皮功能和动脉僵硬的影响。患有2型糖尿病的60名服用二甲双胍、磺脲类药物或同时服用这两种药物的糖尿病控制不佳的患者将被随机分成两组，分别接受兰特斯胰岛素的埃克塞那肽治疗。他们将在开始治疗前进行基线评估，其中包括：血流介导的扩张，以评估内皮依赖的血管扩张，脉搏波分析，以评估动脉僵硬，以及对硝酸甘油的反应，以评估非内皮依赖的血管扩张。这些测试将在饮食耐量测试之前和之后进行，以及实验室指标：内皮功能、炎症和氧化应激，在三个小时的过程中，在不同的时间点进行。然后，受试者将被随机分成两组，分别接受艾塞那肽或兰图斯的治疗。艾塞那肽剂量在4周后增加，兰特斯剂量每隔一周滴定一次，以达到目标空腹血糖。12周后，受试者将返回进行重复的基线研究，以及饮食耐量测试，随后进行重复研究和实验室评估。主要终点将是内皮依赖性血管扩张、内皮非依赖性血管扩张和动脉僵硬。次要终点将包括炎症、内皮功能和氧化应激的标记物。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a randomized, non-blinded, comparative study that will evaluate the effects of Exenatide on endothelial function and arterial stiffness. 60 subjects with poorly controlled diabetes on either Metformin, a Sulfonylurea, or both, with type 2 diabetes will be randomized to treatment with either Exenatide of Lantus insulin. They will have a baseline evaluation prior to starting treatment, which will include: flow mediated dilation, to evaluate the endothelial-dependent vasodilation, pulse wave analysis to assess arterial stiffness, and response to nitroglycerin to evaluate endothelial-independent vasodilation. These tests will be performed both before and after a meal tolerance test, along with laboratory markers: endothelial function, inflammation and oxidative stress, at various time points over the course of three hours. Subjects will then be randomized to treatment with Exenatide or Lantus. Exenatide dose will be increased after 4 weeks, and Lantus dose will be titrated every other week to achieve the target fasting blood glucose. After 12 weeks, subjects will return for repeat baseline studies, as well as a meal tolerance test, with repeat studies and laboratory evaluation afterwards. The primary endpoints will be endothelial-dependent vasodilation, endothelial-independent vasodilation and arterial stiffness. Secondary endpoints will include the markers of inflammation, endothelial function and oxidative stress.