DIABETES CONTROL AND COMPLICATIONS TRIAL

这项拨款提案是对NIH RFA参与一项 20个中心的合作研究，其最终目标是 确定血糖水平是否控制在胰岛素依赖 糖尿病患者是“糖尿病”发展的主要因素， 并发症“这个特殊的应用程序只关注 这个长期项目的可行性试验阶段。 的具体目标 本阶段的目的是确定是否可以（1）随机化 胰岛素依赖型糖尿病患者分为两个治疗组， 常规治疗组和强化治疗组。 (2)通过加大教育力度、控制饮食、胰岛素治疗， 锻炼等等，是否有可能显著改善代谢控制， 特别是血液中的波动的正常化或接近正常化 葡萄糖 (3)这样做是否安全、有效、成本合理 病人是否可以接受？ (4)是否有不良影响， 可能是强化治疗的结果 我们希望招募10名典型的胰岛素缺乏型糖尿病患者， 匹兹堡儿童医院的糖尿病患者 在大学健康中心，将他们随机分为两组， 保持常规治疗的同时， 教育、指导和刺激，以改善代谢控制， 第二组。 患者将进入临床研究 中心进行初始，非常完整的评估，这将在 研究的完成。 干预入院将是 按需要安排。 代谢控制的详细观察结果 此外，还将进行心理评估，包括 入职时会进行认知评估及情绪评估 和终止。 终点测定也将记录在 入组和终止时视网膜血管变化的观察结果，外周 血管改变，周围神经功能，以及详细评估 肾功能和骨钙化

This grant proposal is a response to an NIH RFA to participate in a collaborative 20 center study, the ultimate objective of which is to determine whether the level of blood glucose control in insulin-dependent diabetic patients is a major factor in the development of "diabetic complications." This particular application focuses solely on the feasibility trial phase of this long term project. The specific objectives of this phase are to determine whether it is possible to (1) Randomize insulin dependent diabetic patients into two treatment groups, one a conventional treatment group and the other an intensive treatment group. (2) By increasing the intensity of education, diet control insulin therapy, exercise, etc., is it possible to significantly improve metabolic control, particularly normalization or near normalization of fluctuations in blood glucose. (3) Can this be done safely, effectively, and at reasonable cost and is it acceptable to the patients? (4) Are there adverse effects such as emotional distrubance which may be a consequence of intensive therapy? We expect to recruit 10 classical insulin-deficient diabetic patients from our diabetic clinic populations at the Children's Hospital of Pittsburgh and at the University Health Center, randomize them into two groups, maintaining conventional therapy in one and providing increasing attention, education, direction, and stimulation for improving metabolic control in the second group. The patients will be admitted to the Clinical Research Centers for inital, very complete evaluation and this will be done again at the completion of the study. Intervening hospital admissions will be arranged as deemed necessary. Detailed observations on metabolic control will be carried out in addition, psychological evaluation including cognitive assessment and emotional assessment will be carried out at entry and termination. Endpoint determinations also will be documented with entry and termination observations on retinal vascular changes, peripheral vascular alterations, peripheral nerve function, and detailed assessment of renal function and bone calcification.