12/22 Limited Competition for the Continuation of the Diabetes Prevention Program Outcomes Study (DPPOS) - Clinical Center

血糖调节异常(“血糖异常”)有一个很长的时间过程，从最早 从糖尿病前期到2型糖尿病(T2D)的发病，到临床的发展 可检测到的微血管变化和可测量的动脉粥样硬化，以临床表现 并发症与随之而来的发病率和死亡率。糖尿病预防计划(DPP) 重点关注糖尿病前期的血糖紊乱，并显示出强大的有益效果 生活方式干预(ILS)和二甲双胍(MET)与安慰剂(PLBO)相比，在 在高危人群(n=3234)中预防或推迟T2D的发病超过3年。 DPP还调查和描述了干预措施、表型和遗传型风险 与T2D发育相关的因素，在这些环境中的干预的影响 风险因素，T2D预防的健康经济影响，以及其他感兴趣的结果。 基于这些结果，民进党生活方式计划得到了广泛的实施。民进党 结果研究(DPPOS)探索了在DPP中预防T2D的长期效果 队列，跨越了糖尿病前期和T2D之间的时期，并检查了结果 比三年的民进党需要更多的时间来开发。DPPOS显示出较长期的益处 原始干预对T2D预防和心血管疾病(CVD)风险的影响 各种因素。患微血管疾病的风险在罹患微血管疾病的人中明显更大。 T2D，随病程延长和HbA1c升高而增加。当时没有 不同治疗组在聚集性微血管患病率上的显著差异 结果：然而，与PLBO和MET相比，ILS显著降低了 女性和HbA1c≥携带者发生微血管疾病的比例为6.5%。 在DPPOS第三阶段延长一年期间，我们将保持并继续遵循 具有良好特征和价值的DPPOS队列，并收集以下结果的测量 在协议中描述的。我们将1)执行新的分析来描述异构性 血糖异常的病程及其长期并发症和定义易感性或 抵抗糖尿病、其并发症和常见的慢性衰老状况，以及2) 了解与参与者留存率、遵守协议和 完成测量，并确定是否可以实施替代方法来 提高保留率和遵从性，并扩大数据收集范围。这些目标将提供 对糖尿病前期和糖尿病及其长期结果的重要见解，可能有助于 DPPOS队列的进一步研究潜力。

Abnormal regulation of glycemia (“dysglycemia”) has a very long time course, from the earliest stage of pre-diabetes, to the onset of Type 2 diabetes (T2D), to the development of clinically detectable microvascular changes and measurable atherosclerosis, to clinically manifest complications with attendant morbidity and mortality. The Diabetes Prevention Program (DPP) focused on the pre-diabetes stage of dysglycemia and demonstrated powerful beneficial effects of lifestyle intervention (ILS) and metformin (MET), compared with placebo (PLBO), in preventing or delaying the onset of T2D over a 3-year period in a high-risk population (n=3234). The DPP also investigated and described the interventions, phenotypic and genotypic risk factors associated with T2D development, the effects of the interventions in the setting of these risk factors, the health economic implications of T2D prevention, and other outcomes of interest. Based on these results, the DPP lifestyle program has been widely implemented. The DPP Outcomes Study (DPPOS) has explored the longer-term effects of T2D prevention in the DPP cohort, bridging the period between pre-diabetes and T2D, and has examined outcomes that required more time to develop than the 3-years of DPP. DPPOS showed longer-term salutary effects of the original interventions on T2D prevention and on cardiovascular disease (CVD) risk factors. The risk for microvascular disease was significantly greater in subjects who developed T2D and increased with longer duration and higher hemoglobin A1c (HbA1c). There were no significant differences by treatment group in the prevalence of the aggregate microvascular outcome; however, compared with PLBO and MET, ILS significantly reduced the risk of microvascular disease among women and those with HbA1c ≥6.5%. During the one-year extension of DPPOS Phase 3, we will maintain and continue to follow the well-characterized and valuable DPPOS cohort, and collect measurements of outcomes as described in the protocol. We will 1) perform new analyses to characterize the heterogeneous course of dysglycemia and its long-term complications and factors that define susceptibility or resistance to diabetes, its complications, and common chronic conditions of aging, and 2) explore the factors associated with participant retention, adherence to the protocol and completion of measurements, and determine if alternative methods can be implemented to improve retention and adherence and to expand data collection. These aims will provide important insights into prediabetes and diabetes and their long-term outcomes and could serve the potential further study of the DPPOS cohort.