EFF BASAL/PREMEAL INS STRAT (DETEMIR/ASPART) TO IMP INS SECRETION/ACTION IN T2D

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。 目的：研究诺和诺德公司新胰岛素制剂的最佳胰岛素疗法，以确定其是否能逆转糖毒性(或“糖毒性”)。 研究计划：将研究30(30)名未控制的T2 DM患者。在最初的筛查访问之后，所有受试者都将进入综合临床研究中心(GCRC)，为期两天半。每个受试者将接受三次治疗：1)预治疗；2)步骤1(单独使用地替米尔后×12周)；以及3)步骤2(在地替米加阿司匹林后×12周)。随后，在30名患者中的20名患者(通过计算机生成的过程随机选择)中，将加入门冬氨酸胰岛素，而另外10名患者将仅继续服用地替米胰岛素。以上建议的门诊和住院评估将重复进行。 方法：简而言之，研究设计包括磨合基线评估后的两步方法：第一步：为期三个月的强化地特胰岛素(Levemir)治疗，目的是通过这种独特的胰岛素制剂尽可能最佳地控制血糖。随后将重复进行与基线时相同的测量。步骤2：添加餐前门冬氨酸胰岛素(Novolog)，为期三个月，以检查正常化餐后血糖漂移的额外好处。受试者将接受肝脏和肌肉的MRS扫描。

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. OBJECTIVE: Examine optimal insulin therapy with the new insulin formulations from Novo Nordisk to determine if it reverses glucotoxicity (or "glucolipotoxicity"). RESEARCH PLAN: Thirty (30) patients with uncontrolled T2DM will be studied. After the initial screening visit all subjects will be admitted to the General Clinical Research Center (GCRC) for 2 1/2 days. Each subject will be admitted on three occasions: 1) pre-treatment; 2) Step 1 (after detemir alone x 12 weeks); and 3) Step 2 (after detemir plus aspart x 12 weeks). Following this, insulin aspart will be added to the treatment in 20 of the 30 patients (randomly chosen by a computer generated process) while the other 10 will be just continued on insulin detemir alone. The outpatient and inpatient evaluations proposed above will be repeated. METHODS: In brief, the study design includes a two-step approach after the run-in baseline evaluations: Step 1: a three-month intensive insulin detemir (Levemir) treatment aimed at the best glycemic control possible with this unique insulin formulation. This will be followed by repeat measurements identical to those obtained at baseline. Step 2: addition of pre-meal insulin aspart (Novolog) for three months to examine the additional benefit of normalizing postprandial glucose excursions. Subjects will receive liver and muscle MRS scans.