2/22 Limited Competition for the Continuation of the Diabetes Prevention Program Outcomes Study (DPPOS) - Clinical Center

2/22 继续开展糖尿病预防计划成果研究 (DPPOS) 的有限竞争 - 临床中心

• 批准号: 10156159
• 负责人: DAVID A EHRMANN
• 金额: --
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-08-20 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10156159
• 关键词: Adherence; Affect; Aging; Atherosclerosis; Cardiovascular system; Chronic; Clinical; Cognitive; Cohort Studies; Consent; Consult; Data; Data Collection; Development; Diabetes Mellitus; Diabetes prevention; Follow-Up Studies; Functional disorder; Future; Genetic; Glycosylated hemoglobin A; Heterogeneity; Individual; Infrastructure; Intervention; Life Style; Longitudinal Studies; Machine Learning; Measurable; Measurement; Medicare; Metformin; Methods; Microvascular Dysfunction; Mind; Morbidity - disease rate; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Outcome Study; Participant; Persons; Pharmaceutical Preparations; Phenotype; Placebos; Population; Prediabetes syndrome; Predisposition; Prevalence; Prevention; Process; Protocols documentation; Regulation; Research Personnel; Resistance; Resources; Risk; Risk Factors; Socioeconomic Factors; Time; Visit; Woman; base; cardiovascular disorder risk; clinical center; clinical development; clinical research site; cognitive disability; cohort; cost; data access; diabetes prevention program; economic implication; follow-up; health economics; high risk population; human disease; improved; indexing; insight; interest; intervention effect; lifestyle intervention; metabolomics; mortality; multiple chronic conditions; participant retention; phase 3 study; physically handicapped; preference; prevent; programs; risk variant; treatment group

ABSTRACT 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.

抽象的 血糖异常调节（“血糖异常”）有一个很长的时间过程，从糖尿病前期的最早阶段开始。 糖尿病、2 型糖尿病 (T2D) 的发作、临床可检测的微血管的发展 变化和可测量的动脉粥样硬化，临床表现出伴随发病率的并发症和 糖尿病预防计划（DPP）重点关注糖尿病前期的血糖异常和死亡率。 与相比，生活方式干预 (ILS) 和二甲双胍 (MET) 具有强大的有益作用 安慰剂 (PLBO)，用于在 3 年内预防或延迟高危人群中 T2D 的发作 (n=3234) DPP 还调查并描述了干预措施、表型和基因型风险因素。 与 T2D 发展相关的干预措施对这些危险因素的影响、健康状况 根据这些结果，DPP 预防 T2D 的经济影响以及其他感兴趣的结果。 生活方式计划已得到广泛实施，DPP 结果研究 (DPPOS) 探讨了更长期的问题。 DPP 队列中 T2D 预防的长期效果，弥合了糖尿病前期和 T2D 之间的时期，并已 研究结果需要比 DPPOS 的 3 年时间更长的时间才能实现。 原始干预措施对 T2D 预防和心血管疾病 (CVD) 风险的有益作用 患有 T2D 的受试者发生微血管疾病的风险显着更高。 随着持续时间的延长和糖化血红蛋白 (HbA1c) 的升高而增加，但没有显着差异。 然而，与 PLBO 和 PLBO 相比，治疗组的总体微血管结果发生率； MET、ILS 显着降低了女性和 HbA1c ≥6.5% 的女性患微血管疾病的风险。 在 DPPOS 第三阶段延长一年期间，我们将维持并继续遵循良好的 具有特征性且有价值的 DPPOS 队列，并收集结果测量结果，如 我们将 1) 进行新的分析来表征血糖异常及其异质过程。 长期并发症和定义对糖尿病及其并发症的易感性或抵抗力的因素 常见的慢性衰老状况，2) 探索与参与者保留、依从性相关的因素 协议和测量的完成，并确定是否可以实施替代方法 提高保留率和依从性并扩大数据收集，这些目标将为我们提供重要的见解。 糖尿病前期和糖尿病及其长期结果，并可能有助于进一步研究 DPPOS 队列。