The Studies to Treat Or Prevent Pediatric Type 2 Diabetes--STOPP-T2D

描述(由申请人提供)：本申请寻求资金，以完成自2002年以来在U01合作协议机制下由治疗或预防儿童2型糖尿病研究(STOP-T2D)联盟实施的当前方案。需要再提供4年的资金，以：(1)完成目前的方案和数据库质量控制，(2)启动成果数据和方法的分析和报告，(3)将数据存档并转移到NIDDK中央储存库。这些研究针对的是少数族裔青年。由15个临床中心组成的治疗研究组正在进行两个方案。(1)今天是一项多中心、三组、前瞻性、随机、部分盲法的临床试验。主要目的是评估维持血糖控制的3种治疗方法的安全性和有效性。年龄在10-17岁的受试者(到目前为止有629名)在4年内被招募，在被诊断为T2D的2年内被随机分组，并将被跟踪2-6年。招募计划于2008年9月1日结束，最终随机化和基线数据收集将于2009年2月28日结束，最终后续行动将于2011年2月28日结束。(2)今天的遗传学研究方案将额外招募2500名在18岁之前被诊断为T2D的参与者。主要目的是收集血液和表型信息，用于探索候选基因与2型糖尿病以及肥胖、胰岛素抵抗和胰岛素抵抗心血管并发症之间的关系。招聘工作预计从2008年夏末开始，一直持续到2011年2月28日。预防课题组在42所中学开展健康初级预防试验。一系列试点和可行性研究有助于确定和制定研究目标和干预措施。主要目标是与对照学校相比，在干预中减少与T2D发展相关的风险因素，如肥胖。这项干预措施改变了整个学校的营养和体育活动环境，包括教育和宣传活动。在基线(2006年秋季)时对6000多名六年级学生进行了测量；最终数据在8年级结束时(2009年春季)收集。 与公共卫生相关：最近，儿科人群中2型糖尿病(T2D)和肥胖症(T2D的主要危险因素)的发病率急剧上升，对我们的医疗保健系统产生了重要影响。以往的治疗和预防T2D的研究主要针对成人。STOP-T2D联盟是联邦政府资助的第一批大规模研究项目之一，旨在加深我们对这些问题及其在儿童和青少年中的解决方案的认识和理解。

DESCRIPTION (provided by applicant): This application seeks funding to complete the current protocols being conducted by the Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) consortium under the U01 cooperative agreement mechanism since 2002. Funding is requested for an additional 4 years to: (1) complete the current protocols and database quality control, (2) initiate analysis and report of outcome data and methods, and (3) archive and transfer the data to the NIDDK central repositories. The studies target minority youth. The treatment study group of 15 clinical centers is conducting two protocols. (1) TODAY is a multi-center, 3-arm, prospective, randomized, partially-blinded clinical trial. The primary object is to evaluate the safety and efficacy of 3 treatments to maintain glycemic control. Subjects (N=629 to date) aged 10-17 were recruited over a 4-year period, randomized within 2 years of diagnosis of T2D, and will be followed for 2-6 years. Recruitment is scheduled to end September 1, 2008, final randomization and baseline data collection on February 28, 2009, and final follow-up on February 28, 2011. (2) The TODAY genetics study protocol will enroll an additional 2500 participants who were diagnosed with T2D prior to their 18th birthday. The primary objective is to collect blood and phenotypic information to be used to explore relationships between candidate genes and type 2 diabetes, as well as obesity, insulin resistance, and cardiovascular complications of insulin resistance. Recruitment is expected to start in late summer 2008 and continue until February 28, 2011. The prevention study group is conducting the HEALTHY primary prevention trial in 42 middle schools. A series of pilot and feasibility studies helped to define and develop study objectives and intervention. The primary objective is to reduce risk factors, such as obesity, associated with the development of T2D in intervention compared to control schools. The intervention changes the nutrition and physical activity environment throughout the school and includes educational and promotional events. Over 6000 6th graders were measured at baseline (fall 2006); final data are collected at end of 8th grade (spring 2009). PUBLIC HEALTH RELEVANCE: The recent and precipitous rises in rates of type 2 diabetes (T2D) and in obesity (the primary risk factor for T2D) in the pediatric population have important ramifications for our health care system. Previous research of treatment and prevention of T2D targeted mainly adults. The STOPP-T2D consortium represents one of the first large-scale federally-funded efforts to conduct studies to further our knowledge and understanding of these problems and their solution in children and adolescents.