TREATMENT OPTIONS FOR TYPE 2 DIABETES IN ADOLESCENTS AND YOUTH (TODAY)

青少年 2 型糖尿病的治疗方案（当今）

• 批准号: 8356660
• 负责人: Siripoom V McKay
• 金额: $ 28.23万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-12-01 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8356660
• 关键词: Adolescent; Behavior Therapy; C-reactive protein; Child; Clinical Research; Diagnosis; Double-Blind Method; Failure; Funding; Glycosylated hemoglobin A; Grant; Health Care Costs; Incidence; Life Style; Lipids; Measurement; Measures; Metformin; Microalbuminuria; National Center for Research Resources; Non-Insulin-Dependent Diabetes Mellitus; Physical activity; Principal Investigator; Publishing; Randomized; Randomized Clinical Trials; Research; Research Infrastructure; Resources; Source; Surrogate Markers; Time; United States National Institutes of Health; arm; cost; early onset; experience; glycemic control; illness length; meetings; middle age; nutrition; prevent; programs; prospective; type 2 diabetes in children

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. ABSTRACT The incidence of type 2 diabetes in children has increased dramatically in the past decade. With earlier onset and thus longer duration of disease these children will have increased health care costs; they may also have more complications than someone diagnosed in middle age. There is little published experience on the best treatment to maintain normal glycemia and prevent complications in children with type 2 diabetes. This trial will determine which of 3 treatments is most effective in maintaining glycemic control. Although the trial will not be long enough to assess if there is a significant difference in complications between these 3 arms, surrogate markers associated with complications will be measured (e.g., lipid profile, C-reactive protein, microalbuminuria). This is a prospective, partially double-blinded, randomized clinical trial with 3 treatment arms: metformin alone, metformin plus intensive lifestyle treatment (behavior modification program). The primary endpoint is time to failure defined as hemoglobin A1c or =8% for 6 or more consecutive months. Subjects will be seen every 1 to 4 weeks during the 2-6 months of the runnin. After randomization, subjects will be seen every 2 months in the first year and every 3 months in subsequent years. In addition, subjects in the lifestyle arm will meet with a PAL (physical activity and nutrition leader) once a week for the first 6 months, every 2 weeks in the 2nd 6 months and monthly thereafter. Endpoint measurements will be done at randomization, 6 months, 24 months and end of study.

这个子项目是许多利用资源的研究子项目之一 由NIH/NCRR资助的中心拨款提供。子项目的主要支持 而子项目的主要调查员可能是由其他来源提供的， 包括其它NIH来源。 列出的子项目总成本可能 代表子项目使用的中心基础设施的估计数量， 而不是由NCRR赠款提供给子项目或子项目工作人员的直接资金。 摘要 儿童2型糖尿病的发病率在过去十年中急剧增加。 由于发病较早，因此疾病持续时间较长，这些儿童的医疗保健费用将增加;他们也可能比中年人诊断出的并发症更多。 关于维持2型糖尿病儿童正常血糖和预防并发症的最佳治疗方法，几乎没有发表过经验。 本试验将确定3种治疗方法中哪一种在维持血糖控制方面最有效。 虽然试验时间不足以评估这3组之间的并发症是否存在显著差异，但将测量与并发症相关的替代标志物（例如，血脂谱、C反应蛋白、微量白蛋白尿）。 这是一项前瞻性、部分双盲、随机化临床试验，有3个治疗组：二甲双胍单药治疗、二甲双胍加强化生活方式治疗（行为矫正计划）。 主要终点是至失败的时间，定义为连续6个月或更长时间血红蛋白A1 c ≥ 8%。 在运行的2-6个月期间，每1 - 4周一次观察受试者。 随机化后，受试者将在第一年每2个月接受一次访视，在随后几年每3个月接受一次访视。 此外，生活方式组的受试者将在前6个月每周一次与PAL（体力活动和营养负责人）会面，在第2个6个月每2周一次，此后每月一次。 将在随机化、6个月、24个月和研究结束时进行终点测量。