STUDIES TO TREAT OR PREVENT PEDIATRIC TYPE 2 DIABETES (STOPP-T2D): TREATMENT

治疗或预防儿童 2 型糖尿病 (STOPP-T2D) 的研究：治疗

• 批准号: 7368243
• 负责人: MITCHELL GEFFNER
• 金额: $ 2.94万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7368243
• 关键词: STUDIES; TREAT; PREVENT; PEDIATRIC; TYPE

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 (T2DM). The secondary aims are to: a) compare and evaluate the safety of the three treatment arms; b) 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 (QoL), and psychological outcomes; c) evaluate the influence of individual and family behaviors on treatment response; and d) compare the relative cost-effectiveness of the three treatment arms. The three treatment regimens are: : (1) metformin alone versus metformin plus intensive lifestyle intervention called the TODAY Lifestyle Program (TLP), (2) metformin alone versus metformin plus rosiglitazone, and (3) 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NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。今日试验的主要目的是将三个治疗臂的疗效在10-17岁患者患有2型糖尿病（T2DM）的受试者中基于血糖控制的治疗失败。次要目的是：a）比较和评估三个治疗臂的安全性； b）将三种处理对T2DM病理生理学的影响与B细胞功能和胰岛素抵抗，身体成分，营养，体育活动以及有氧运动健康，心血管危险因素，微血管危险因素，微血管并发症，生活质量（QOL）以及心理局势的影响； c）评估个人和家庭行为对治疗反应的影响； d）比较三个治疗臂的相对成本效益。三种治疗方案是：：（1）单独使用二甲双胍与二甲双胍加密集的生活方式干预措施，称为“今日生活方式”计划（TLP），（2）单独使用二甲双胍与二甲双胍加上麦克列酮，以及（3）二甲双胍加上TLP和tlp versus vess v versus tlp versus vessus vess vess versus versus versus vessus vess v vess v vess versus versus versus versus versus vessus vessus vessus vess v vess v vess。该研究在三年内招募了受试者，并至少招募了两年。受试者在T2DM诊断后的两年内随机分组。治疗失败的主要结果是根据HBA1C（在6个月内= 8.0％）或无法断奶临时胰岛素的定义。