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

12/22 继续进行糖尿病预防计划成果研究 (DPPOS) 的有限竞争 - 临床中心

• 批准号: 10653523
• 负责人: MARIA ROSARIO GORREZ ARANETA
• 金额: $ 12.62万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-09-10 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10653523
• 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

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.

血糖的异常调节（“血糖症”）从最早的时间开始有很长的时间。 糖尿病前期的糖尿病阶段，到2型糖尿病（T2D）的发作 可检测的微血管变化和可测量的动脉粥样硬化，从临床上表现出来 随之而来的发病率和死亡率并发症。糖尿病预防计划（DPP） 专注于糖尿病的糖尿病前阶段，并表现出强大的有益作用 与安慰剂（PLBO）相比，生活方式干预（ILS）和二甲双胍（Met）的 防止或延迟在高危人群中3年内T2D发作（n = 3234）。 DPP还研究并描述了干预措施，表型和基因型风险 与T2D开发相关的因素，这些干预措施在这些情况下的影响 风险因素，预防T2D的健康经济影响以及其他感兴趣的结果。 基于这些结果，DPP生活方式计划已被广泛实施。 DPP 结果研究（DPPO）探讨了T2D预防在DPP中的长期影响 队列，桥接糖尿病前和T2D之间的时期，并检查了结果 比DPP的3年需要更多的时间发展。 DPPO显示长期有益的 原始干预措施对T2D预防和心血管疾病（CVD）风险的影响 因素。在发展的受试者中，微血管疾病的风险明显更大 T2D并随持续时间较长和更高的血红蛋白A1C（HBA1C）增加。没有 治疗组的显着差异在总微血管的患病率中 结果;但是，与PLBO和MET相比，ILS显着降低了 女性和HBA1C≥6.5％的女性微血管疾病。 在DPPOS第3阶段的一年延长期间，我们将维持并继续遵循 特征且有价值的DPPOS队列，并收集结果的测量 在协议中描述。我们将1）执行新分析以表征异质 血糖及其长期并发症和因素定义易感性或 对糖尿病的抵抗力，其并发症和衰老的常见慢性条件，2） 探索与参与保留，遵守协议相关的因素以及 完成测量，并确定是否可以实施替代方法 改善保留和依从性并扩大数据收集。这些目标将提供 对糖尿病和糖尿病及其长期结局的重要见解，可以服务 DPPO队列的潜在进一步研究。

项目成果

Prevalence of Distal Symmetrical Polyneuropathy by Diabetes Prevention Program Treatment Group, Diabetes Status, Duration of Diabetes, and Cumulative Glycemic Exposure.

糖尿病预防计划治疗组远端对称性多发性神经病的患病率、糖尿病状况、糖尿病持续时间和累积血糖暴露。

• DOI: 10.2337/dc23-2009
• 发表时间: 2024
• 期刊: Diabetes care
• 影响因子: 16.2
• 作者: Lee,ChristineG;Ciarleglio,Adam;Edelstein,SharonL;Crandall,JillP;Dabelea,Dana;Goldberg,RonaldB;Kahn,StevenE;Knowler,WilliamC;Ma,MaxwellT;White,NeilH;Herman,WilliamH;DiabetesPreventionProgramResearchGroup
• 通讯作者: DiabetesPreventionProgramResearchGroup