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: 10459025
• 负责人: MARIA ROSARIO GORREZ ARANETA
• 金额: $ 10.17万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10459025
• 关键词: Adherence; Administrative Supplement; Aging; Appointment; Atherosclerosis; COVID-19 pandemic; California; Cardiovascular Diseases; Cardiovascular system; Categories; Chronic; Clinic; Clinic Visits; Clinical; Clinical Trials; Clinical assessments; Cognitive; Cohort Studies; Data; Data Collection; Development; Diabetes Mellitus; Diabetes prevention; Ensure; Ethnic Origin; Event; Functional disorder; Funding; Glycosylated hemoglobin A; Grant; Health; Heart Diseases; Heterogeneity; Holidays; Human Resources; Incidence; Institutes; Institution; Intervention; Laboratories; Leadership; Life Style; Logistics; Long-Term Effects; Malignant Neoplasms; Measurable; Measurement; Medical History; Medical Records; Metformin; Methods; Microvascular Dysfunction; Morbidity - disease rate; Neuropathy; Non-Insulin-Dependent Diabetes Mellitus; Nursing Research; Outcome; Outcome Study; Parents; Participant; Peripheral Nervous System Diseases; Persons; Phenotype; Physical Function; Placebos; Policies; Postdoctoral Fellow; Prediabetes syndrome; Predisposition; Prevalence; Prevention; Protocols documentation; Questionnaires; Race; Regulation; Renal function; Reporting; Research; Resistance; Retinal Diseases; Risk; Risk Factors; Role; SARS-CoV-2 infection; Safety; Site; Telephone; Time; Training; U-Series Cooperative Agreements; United States National Institutes of Health; Universities; Visit; Woman; base; cardiovascular disorder risk; cardiovascular risk factor; clinical center; clinical development; cohort; diabetes prevention program; economic implication; health economics; high risk population; human disease; improved; infection rate; insight; interest; intervention effect; intervention program; lifestyle intervention; mortality; pandemic disease; parent grant; participant retention; phase 3 study; prevent; programs; risk variant; sex; treatment group

Project Summary 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.

项目摘要 从最早的前阶段开始，血糖异常调节（“血糖”）的病程很长 糖尿病，到2型糖尿病（T2D）的发作，到临床可检测的微血管发育 变化和可测量的动脉粥样硬化，在临床上与随之而来的发病率和并发症 死亡。糖尿病预防计划（DPP）着重于血糖前糖尿病前期和 与生活方式干预（ILS）和二甲双胍（MET）相比，表现出强大的有益作用 安慰剂（PLBO），预防或延迟在3年的高风险人群中T2D发作 （n = 3234）。 DPP还研究并描述了干预措施，表型和基因型危险因素 与T2D开发相关，干预措施在这些风险因素的设置中的影响，健康 T2D预防的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）探索了更长的 T2D预防在DPP队列中的术语效应，桥接糖尿病前和T2D之间的时期，并且具有 检查的结果比3年的DPP需要更多的时间发展。 DPPO显示长期 原始干预措施对T2D预防和心血管疾病（CVD）风险的有益影响 因素。在开发T2D和 持续时间更长，血红蛋白A1C（HBA1C）增加。没有明显的差异 总体微血管结局的患病率的治疗组；但是，与PLBO相比 并满足，ILS显着降低了女性和HBA1C患者的微血管疾病的风险 ≥6.5％。 在DPPOS第3阶段的一年延长期间，我们将维持并继续遵循 表征且有价值的DPPO队列，并收集结果的测量 协议。我们将1）进行新的分析，以表征血糖及其异质过程 长期并发症和因素定义了对糖尿病的敏感性或抗性，其并发症以及 衰老的常见慢性疾病，2）探索与参与保留相关的因素， 遵守协议和完成测量，并确定是否可以替代方法 实施以提高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，并可能有潜力 进一步研究DPPO队列。