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

治疗或预防儿童 2 型糖尿病的研究--STOPP-T2D

• 批准号: 8039669
• 负责人: KATHRYN HIRST
• 金额: $ 110.26万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-15 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8039669
• 关键词: Address; Adolescent; Adult; Archives; Blood; Candidate Disease Gene; Cardiovascular system; Child; Childhood; Clinical; Clinical Trials; Data; Data Collection; Data Coordinating Center; Databases; Development; Diagnosis; Enrollment; Environment; Event; Feasibility Studies; Federal Government; Funding; Genetic; Healthcare Systems; Individual; Institution; Insulin Resistance; Intervention; Knowledge; Logistics; Measures; Methods; Minority; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Outcome; Participant; Pharmaceutical Preparations; Physical activity; Population; Preparation; Prevention; Primary Prevention; Process; Protocols documentation; Quality Control; Randomized; Recruitment Activity; Reporting; Research; Research Infrastructure; Risk Factors; Safety; Sample Size; Schedule; Schools; Series; Site; Solutions; Staging; Time; U-Series Cooperative Agreements; Youth; aged; arm; falls; follow-up; glycemic control; middle school; nutrition; prevent; prospective; public health relevance; repository; type 2 diabetes in children

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.

描述（由申请人提供）：本申请寻求资金来完成治疗或预防儿童 2 型糖尿病研究 (STOPP-T2D) 联盟自 2002 年以来根据 U01 合作协议机制进行的现行方案。请求额外资助 4 年，以：(1) 完成现行方案和数据库质量控制，(2) 启动结果数据和方法的分析和报告，以及 (3) 存档和传输数据 到 NIDDK 中央存储库。这些研究针对的是少数民族青年。由 15 个临床中心组成的治疗研究小组正在实施两项方案。 (1) TODAY 是一项多中心、三臂、前瞻性、随机、部分盲法临床试验。主要目的是评估 3 种治疗方法维持血糖控制的安全性和有效性。 10-17 岁的受试者（迄今为止 N=629）在 4 年的时间内被招募，在诊断为 T2D 后的 2 年内随机分组，并将随访 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于 2009 年 2 月 28 日结束，最终随访于 2011 年 2 月 28 日结束。 (2) TODAY 遗传学研究方案将另外招募 2500 名在 18 岁生日之前被诊断患有 T2D 的参与者。主要目标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的心血管并发症之间的关系。招募预计于2008年夏末开始，一直持续到2011年2月28日。预防研究小组正在42所中学进行HEALTHY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。与对照学校相比，干预措施的主要目标是减少与 T2D 发生相关的危险因素，例如肥胖。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。对 6000 多名六年级学生进行了基线测量（2006 年秋季）；最终数据在八年级结束时（2009 年春季）收集。 公共卫生相关性：儿科人群中 2 型糖尿病 (T2D) 和肥胖（T2D 的主要危险因素）发病率近期急剧上升，对我们的医疗保健系统产生了重要影响。先前关于 T2D 治疗和预防的研究主要针对成年人。 STOPP-T2D 联盟是首批由联邦政府资助的大规模研究项目之一，旨在进一步了解和理解儿童和青少年的这些问题及其解决方案。