Diabetes Research in Children Network (DirecNet)

儿童糖尿病研究网络 (DirecNet)

• 批准号: 8120962
• 负责人: Neil H. White
• 金额: $ 30.81万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-27 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8120962
• 关键词: Address; Adolescent; Adrenergic Agonists; Age; Asthma; Bronchodilator Agents; Child; Clinical Trials; Collaborations; Complications of Diabetes Mellitus; Controlled Clinical Trials; Data; Data Analyses; Diabetes Mellitus; Dose; Double-Blind Method; Exercise; Failure; Glucose; Hormones; Hyperglycemia; Hypoglycemia; Incidence; Institution; Insulin; Insulin-Dependent Diabetes Mellitus; Intervention; Investigational Drugs; Neurocognitive; Neuropathy; Oral; Pharmaceutical Preparations; Physiological; Pilot Projects; Placebo Control; Placebos; Premature Labor; Prevention; Prevention strategy; Randomized; Research; Research Personnel; Research Proposals; Rest; Risk; Series; Sleep; Study Subject; Terbutaline; Tocolytic Agents; Weight; Work; base; cognitive function; counterregulation; diabetes control; diabetic; dosage; glycemic control; hypoglycemia unawareness; improved; prevent; protocol development; response; type I diabetic; waiver; young adult; Address; Adolescent; Adrenergic Agonists; Age; Asthma; Bronchodilator Agents; Child; Clinical Trials; Collaborations; Complications of Diabetes Mellitus; Controlled Clinical Trials; Data; Data Analyses; Diabetes Mellitus; Dose; Double-Blind Method; Exercise; Failure; Glucose; Hormones; Hyperglycemia; Hypoglycemia; Incidence; Institution; Insulin; Insulin-Dependent Diabetes Mellitus; Intervention; Investigational Drugs; Neurocognitive; Neuropathy; Oral; Pharmaceutical Preparations; Physiological; Pilot Projects; Placebo Control; Placebos; Premature Labor; Prevention; Prevention strategy; Randomized; Research; Research Personnel; Research Proposals; Rest; Risk; Series; Sleep; Study Subject; Terbutaline; Tocolytic Agents; Weight; Work; base; cognitive function; counterregulation; diabetes control; diabetic; dosage; glycemic control; hypoglycemia unawareness; improved; prevent; protocol development; response; type I diabetic; waiver; young adult

DESCRIPTION (provided by applicant): Section 1 summarizes the qualifications of the investigators and institution (WUMS) to actively participate intellectually and operationally in protocol development, implementation, analysis of data and dissemination of results related to studies to be conducted by this Network for the prevention of hypoglycemia in insulin-treated diabetic subjects. Section 2 will outline a specific proposal for consideration by the Network. The specific proposal presented herein is entitled "Bedtime p2-adrenergic agonist therapy to prevent hypoglycemia in children with type 1 diabetes". Our proposal is based on studies, including those from our own group and other investigators, related to hypoglycemia-associated autonomic failure (HAAF) and its related components (defective glucose counterregulation, hypoglycemia unawareness, exercise-related HAAF, sleep-related HAAF) and thier association with the risk of hypoglycemia, and our preliminary studies suggesting that the p2-adrenergic agonist, terbutaline, diminishes nocturnal hypoglycemia in insulin-treated type 1 diabetic subjects. Herein, we propose initial pilot studies to determine the best dosage of terbutaline for the safe prevention of nocturnal hypoglycemia and to explore the physiologic effects of terbutaline on nocturnal hypoglycemia, hypoglycemia counterregulation and sleep efficiency. We then propose to use the results of these pilot studies and the collaborations established through this Network to develop and implement a large, multicenter, randomized, double-blind, placebo-controlled clinical trial to determine whether bedtime terbutaline reduces hypoglycemia to a degree that enables improvement of overall glycemic control. We also propose exploratory studies of the risks of hypo- and hyperglycemia on cognitive function. Establishing optimal glycemic control at the level necessary to achieve and maintain reduction of long term microvascular, macrovascular and neuropathic complications of diabetes has been limited by the risk of hypoglycemia. Strategies to prevent hypoglycemia that would enable better overall glycemic control would represent an important advance in the management of insulin-requiring diabetes mellitus. This research Network will develop and evaluate strategies to prevent hypoglycemia and improve diabetes control.

描述（申请人提供）：第1节总结了研究人员和机构（WUMS）的资格，以在智力和运营上积极参与协议开发，实施，数据分析以及与该网络有关的研究结果的结果，以预防胰岛素培养的糖尿病糖尿病患者。第2节将概述网络考虑的特定建议。本文提出的具体建议标题为“就寝时间P2-肾上腺素能治疗，以防止1型糖尿病儿童低血糖”。 Our proposal is based on studies, including those from our own group and other investigators, related to hypoglycemia-associated autonomic failure (HAAF) and its related components (defective glucose counterregulation, hypoglycemia unawareness, exercise-related HAAF, sleep-related HAAF) and thier association with the risk of hypoglycemia, and our preliminary studies suggesting that the p2-adrenergic agonist, Terbutaline，胰岛素治疗1型糖尿病患者中的夜间低血糖减少。在本文中，我们提出了初步的试点研究，以确定tbutaline的最佳剂量，以安全预防夜间低血糖，并探索Terbutaline对非血糖低血糖，高血糖症的低血糖反调控和睡眠效率的生理影响。然后，我们建议使用这些试点研究的结果以及通过该网络建立的合作来开发和实施大型，多中心，随机，双盲，安慰剂对照的临床试验来确定terbutaline tertime tertime降低低血糖是否能够改善整体血糖控制的程度。我们还提出了关于低血糖对认知功能的风险的探索性研究。在糖尿病的长期微血管，大血管和神经性并发症的降低所必需的水平上建立最佳的血糖控制受到低血糖风险的限制。预防低血糖的策略将使更好的总体血糖控制能够代表治疗胰岛素糖尿病的重要进步。该研究网络将制定并评估防止低血糖症并改善糖尿病控制的策略。