TRIPOD (TRoglitazone in the Prevention of Diabetes): A randomized, placebo-controlled trial of troglitazone in women with prior gestational diabetes mellitus
TRIPOD (TRoglitazone in the Prevention of Diabetes): A randomized, placebo-controlled trial of troglitazone in women with prior gestational diabetes mellitus
复制标题
DOI：
10.1016/s0197-2456(97)00151-7
复制
发表时间：
1998-04-01
期刊：
影响因子：
--
通讯作者：
Buchanan, TA
中科院分区：
文献类型：
--
作者：
Azen, SP;Peters, RK;Buchanan, TA
TRIPOD试验是一项单中心、随机、安慰剂对照、双盲研究。TRIPOD试验的主要目的是检验以下假设：既往患有妊娠糖尿病（GDM）的非糖尿病女性长期给予曲格列酮将改善全身胰岛素敏感性并降低非胰岛素依赖型糖尿病（NIDDM）的发生率。由于已知曲格列酮可降低NIDDM患者的血糖浓度，因此本项目的另一个目的是确定早期使用曲格列酮干预是否能比后期干预更好地控制最终血糖。此外，由于曲格列酮治疗有望改善胰岛素敏感性，并可能预防或延迟葡萄糖耐量下降，我们还计划确定长期曲格列酮治疗是否改变动脉粥样硬化的发展或进展。在本文中，我们描述了实验的设计，研究的终点和确定这些终点的方法，评估生活质量的方法，TRIPOD试验独特的两阶段研究设计不仅允许测试关于胰岛素抵抗逆转和预防糖尿病的生物学问题，而且还允许测试关于早期干预是否上级晚期干预的临床问题。这项试验的结果将对NIDDM高危患者的监测和治疗产生重要影响。(C)Elsevier Science Inc. 1998.
The TRoglitazone In the Prevention Of Diabetes (TRIPOD) trial is a single-center, randomized, placebo-controlled, double-masked study. The primary aim of the TRIPOD trial is to test the hypothesis that chronic administration of troglitazone to nondiabetic women with prior gestational diabetes mellitus (GDM) will improve whole-body insulin sensitivity and reduce the incidence of non-insulin-dependent diabetes (NIDDM). Because troglitazone is already known to lower blood glucose concentrations in persons who have developed NIDDM, an additional aim of the project will be to determine whether early intervention with troglitazone will achieve better final glycemic control than can be achieved by later intervention. hn addition, since troglitazone treatment is expected to improve insulin sensitivity and may prevent or delay a decline in glucose tolerance, we also plan to determine whether long-term troglitazone treatment alters the development or progression of atherosclerosis.In this article we describe the experiment's design, the study's endpoints and methods for determining those endpoints, methods for assessing quality of life, and proposed methods for statistical analyses.The unique two-phase study design of the TRIPOD trial will permit testing not only of the biological question about reversal of insulin resistance and prevention of diabetes, but also of the clinical question about whether early intervention is superior to late intervention. Results from this trial will have an important impact on the monitoring and treatment of patients at high risk for NIDDM. (C) Elsevier Science Inc. 1998.