CLINICAL TRIAL: STUDIES TO TREAT OR PREVENT PEDIATRIC TYPE 2 DIABETES (STOPP-T2D

临床试验：治疗或预防儿童 2 型糖尿病 (STOPP-T2D) 的研究

• 批准号: 7982152
• 负责人: MITCHELL GEFFNER
• 金额: $ 5.22万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7982152
• 关键词: 17 year old; Aerobic; Behavior; Body Composition; Cell physiology; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Diabetic Angiopathies; Diagnosis; Family; Functional disorder; Funding; Glycosylated hemoglobin A; Grant; Individual; Institution; Insulin; Insulin Resistance; Life Style; Metformin; Non-Insulin-Dependent Diabetes Mellitus; Physical activity; Quality of life; Randomized; Recruitment Activity; Relative (related person); Research; Research Personnel; Resources; Safety; Source; Time; Treatment Failure; Treatment Protocols; United States National Institutes of Health; Upper arm; Weaning; base; cardiovascular risk factor; comparative efficacy; cost effectiveness; fitness; glycemic control; lifestyle intervention; nutrition; prevent; primary outcome; programs; psychological outcomes; rosiglitazone; treatment response

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objective of the TODAY trial is to compare the efficacy of the three treatment arms on time to treatment failure based on glycemic control in subjects from 10-17 years of age with type 2 diabetes mellitus. The secondary aims are to: compare and evaluate the safety of the three treatment arms; compare the effects of the three treatments on the pathophysiology of T2DM with regards to b-cell function and insulin resistance, body composition, nutrition, physical activity, and aerobic fitness, cardiovascular risk factors, microvascular complications, quality-of-life, and psychological outcomes; evaluate the influence of individual and family behaviors on treatment response; and compare the relative cost-effectiveness of the three treatment arms. The three treatment regimens are: : metformin alone versus metformin plus intensive lifestyle intervention called the TODAY Lifestyle Program; metformin alone versus metformin plus rosiglitazone, and; metformin plus TLP versus metformin plus rosiglitazone. The study recruits subjects over a three-year period and follows them for a minimum of two years. Subjects are randomized within two years of the diagnosis of T2DM. The primary outcome of treatment failure is defined in terms of HbA1c 8.0% over a 6-month period; or inability to wean off temporary insulin.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 TODAY 试验的主要目的是根据 10-17 岁 2 型糖尿病受试者的血糖控制情况，比较三个治疗组按时治疗失败的疗效。 次要目标是： 比较和评估三个治疗组的安全性； 比较三种治疗方法对 T2DM 病理生理学的影响，包括 B 细胞功能和胰岛素抵抗、身体成分、营养、体力活动和有氧健身、心血管危险因素、微血管并发症、生活质量和心理结果； 评估个人和家庭行为对治疗反应的影响；和 比较三个治疗组的相对成本效益。 三种治疗方案是：：单独二甲双胍与二甲双胍加强化生活方式干预（称为“今日生活方式计划”）；单独使用二甲双胍与二甲双胍联合罗格列酮比较；二甲双胍加 TLP 与二甲双胍加罗格列酮。 该研究招募了为期三年的受试者，并跟踪他们至少两年。 受试者在诊断为 T2DM 后两年内被随机分配。 治疗失败的主要结局定义为 6 个月内 HbA1c 为 8.0%；或无法暂时停用胰岛素。