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 异常调节（“功能障碍”）具有很长的时间过程，从最早期的前- 2型糖尿病（T2 D）的发病，临床上可检测到的微血管病变的发展， 变化和可测量的动脉粥样硬化，临床上表现出并发症伴随发病率， mortality.糖尿病预防计划（DPP）的重点是糖尿病前阶段的精神障碍， 与之相比，生活方式干预（ILS）和二甲双胍（MET）表现出强大的有益作用 安慰剂（PLBO），在高危人群中预防或延迟T2 D发作3年 （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T2 D发展相关，在这些风险因素的背景下干预措施的效果， T2 D预防的经济影响以及其他感兴趣的结果。根据这些结果，民进党 生活方式方案得到广泛实施。民进党成果研究（DPPOS）探讨了更长的- DPP队列中T2 D预防的长期效应，桥接糖尿病前期和T2 D之间的时期， 审查了需要比3年DPP更长时间来开发的结果。DPPOS显示长期 原始干预措施对T2 D预防和心血管疾病（CVD）风险的有益影响 因素发生T2 D和T2 D的受试者发生微血管疾病的风险显著更高， 随着病程的延长和糖化血红蛋白（HbA 1c）的升高而升高。在以下方面没有显著差异： 治疗组的总体微血管结局患病率;然而，与PLBO相比， 和MET，ILS显著降低了女性和HbA 1c患者微血管疾病的风险 ≥ 6.5%。 在计划第三期延长一年期间，我们会维持并继续遵循良好的- 特征和有价值的DPPOS队列，并收集结果的测量，如 议定书我们将1）进行新的分析，以表征精神障碍的异质性过程及其 长期并发症和定义糖尿病易感性或抵抗性的因素，其并发症，以及 常见的慢性衰老状况，以及2）探索与参与者保留相关的因素， 遵守方案并完成测量，并确定是否可以使用替代方法 实施该系统的目的是改进数据保留和遵守情况，并扩大数据收集。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，并可能有助于 DPPOS队列的进一步研究。