DIABETES CONTROL AND COMPLICATIONS TRIAL

在本申请中，我们建议成为20个临床中心之一 参与一项合作临床试验， 血糖控制和血管并发症之间的关系 胰岛素依赖型糖尿病。 在制定最终方案之后 与其他临床中心和NIAMDD工作人员一起，我们将随机抽取10名 10 - 28岁的胰岛素依赖型糖尿病患者， 常规治疗，包括饮食、运动和分剂量胰岛素，或 强化治疗方案 这些患者将被仔细检查。 指导和遵循，以便精确的糖尿病代谢控制， 通过便携式胰岛素泵和/或频繁注射 胰岛素 所有患者最初将住院进行基线研究， 心理测试，教育和调整治疗的一般 临床研究中心。 主要终点为光学 眼底照相和神经传导时间。 血管指数为 其次是尿蛋白、脂质和脂蛋白、血小板 功能，血小板和内皮细胞前列环素代谢，激肽释放酶 和激肽。 患者将进行HLA分型，器官特异性抗体和 免疫复合物测定。 预计在两年期间， 这项可行性研究，它可以确定，如果严格控制 方案是可行的并且具有高度的患者可接受性。 此外，本发明还 应该能够建立评估和监测的方法， 代谢控制和病理并发症的发生， 用于随后的全面临床试验。

In this application, we propose to be one of 20 clinical centers selected to participate in a collaborative clinical trial on the relationship between blood glucose control and vascular complications in patients with insulin-dependent diabetes mellitus. After development of a final protocol with other clinical centers and the NIAMDD staff, we will randomize 10 insulin-dependent diabetic patients between the ages of 10 and 28 to conventional therapy with diet, exercise, and split doses of insulin or to an intensive therapy regimen. These latter patients will be carefully instructed and followed so that precise metabolic control of diabetes can be achieved by portable insulin pump and/or frequent injections of insulin. All patients will be initially hospitalized for baseline studies, psychological testing, education and adjustment of therapy on the General Clinical Research Center. Major end points to be followed will be optic fundus photography and nerve conduction times. Vascular indices to be followed will include urinary protein, lipids and lipoproteins, platelet function, prostacyclin metabolism of platelets and endothelium, kallikrein and kinins. Patients will have HLA typing, organ-specific antibodies and immune complexes determined. It is expected that over the two year period of this feasibility study that it can be determined if a strict control regimen is feasible and has high degree of patient acceptability. Further, it should be possible to establish methods for assessing and monitoring metabolic control and enpoints of pathologic complications which can be used in a subsequent full-scale clinical trial.