DIABETES CONTROL AND COMPLICATIONS TRIAL

在本申请中，我们建议成为选定的20个临床中心之一 参与一项关于这一关系的合作临床试验 糖尿病患者血糖控制与血管并发症的关系 胰岛素依赖型糖尿病。在制定了最终协议之后 与其他临床中心和NIAMDD工作人员一起，我们将随机选择10个 年龄在10岁到28岁之间的胰岛素依赖型糖尿病患者 传统的治疗方法包括节食、锻炼和分剂量的胰岛素或 强化治疗方案。这些后一批患者将会小心 指导和遵循，以便糖尿病的精确代谢控制可以 可通过便携式胰岛素泵和/或频繁注射 胰岛素。所有患者最初都将住院进行基线研究， 心理测验、心理教育与心理调适对一般人群的影响 临床研究中心。接下来的主要终点将是光学 眼底照相和神经传导时间。血管指数为 其次是尿蛋白、血脂和脂蛋白、血小板 血小板和内皮的功能、前列环素代谢、激肽释放酶 还有激动素。患者将进行人类白细胞抗原配型，器官特异性抗体和 确定了免疫复合体。预计在这两年期间， 这项可行性研究可以确定是否有严格的控制 治疗方案可行，患者可接受性高。此外， 应该有可能建立评估和监测的方法 代谢控制和病理并发症的要点 在随后的全面临床试验中使用。

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.