TODAY2 Phase 1 Immediate Post-Intervention Observational Follow-up Study of the TODAY Clinical Trial Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 550
- 试验地点
- 16
- 主要终点
- effects of TODAY treatment assignment on long-term glycemic control
研究概览
简要总结
The purpose of this study is to continue to follow participants in the TODAY clinical trial as they transition to non-blinded, non-randomized standard diabetes care and management with monitoring and follow-up for up to 24 months (phase 1), during which time the TODAY data are analyzed and findings interpreted to develop a long-term observational protocol (phase 2). Data are collected during phase 1 for descriptive purposes; there is no primary hypothesis.
详细描述
TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) was a multi-center study of the optimal approach to treatment of type 2 diabetes (T2D) in children and adolescents. The TODAY clinical trial of experimental interventions ended in February 2011. It is followed by TODAY2, a longitudinal study to continue the care and observation of the TODAY cohort beyond the end of the TODAY intervention trial. TODAY2 consists of two phases.
- First is the immediate transition of TODAY participants to non-blinded, non-randomized standard diabetes care and management with monitoring and follow-up for up to 24 months. During this period, the findings of TODAY are analyzed and interpreted by the study group.
- The second phase is a protocol for long-term longitudinal follow-up of the TODAY cohort, based on findings from TODAY.
The primary objective of the first phase of TODAY2 is to continue to follow the TODAY subjects for up to 24 months in order to begin to:
- understand the persistence of the effects of the different treatment regimens used in TODAY,
- describe the continued evolution of beta cell function, and
- describe the development of vascular complications and risk factors for complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participated in the TODAY clinical trial.
- •Provided informed consent to participate in T2P1.
排除标准
- 未提供
结局指标
主要结局
effects of TODAY treatment assignment on long-term glycemic control
时间窗: observed for 2 years in phase 1
The primary objective of the first phase of TODAY2 is to begin to examine the persistence of effects of the TODAY treatment assignment on long-term glycemic control following discontinuation of randomized treatment. During this period, results of TODAY are produced and used to define additional outcomes for the second phase of TODAY2.
次要结局
- glycemic control(observed for 2 years in phase 1)
- safety(observed for 2 years in phase 1)
- insulin sensitivity and secretion(observed for 2 years in phase 1)
- cardiovascular risk factors(observed for 2 years in phase 1)
- microvascular complications(observed for 2 years in phase 1)
研究者
Kimberly
Principal Investigator of Coordinating Center
George Washington University