DIABETES PREVENTION PROGRAM OUTCOMES STUDY (DPPOS)

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项名为糖尿病预防计划结果研究(DPPOS)的长期跟踪研究旨在进一步利用DPP志愿者的科学和临床价值队列以及在研究期间收集的大量数据来解决上述问题。高度不满的民进党队列，包括45%的少数民族，是有史以来研究过的最大的IGT人群。此外，大量新发的2型糖尿病患者从他们真正发病的时候开始仔细跟踪，为研究2型糖尿病的临床病程提供了一个无与伦比的机会。 目的：DPPOS的主要目标是评估积极的DPP干预措施对a)糖尿病在未来5-10年的发展和b)糖尿病相关的微血管病变和心血管疾病的综合结果的长期影响。正在测试的假设是，与以前的安慰剂组相比，持续的生活方式干预和二甲双胍都将继续分离糖尿病的发展速度，而在DPP和DPPOS期间预防或推迟糖尿病将转化为综合结果的降低和健康状况的改善。 DPPOS的次要目标是评估DPP干预措施对选定的个人健康结果的长期影响，这些结果的既定和推定的风险因素，以及与延迟或预防糖尿病相关的成本和成本效益。 其他研究目标包括检查和比较新发糖尿病和糖耐量低减参与者的这些健康结果的发生率和决定因素，以及评估参与者的分组，以评估种族/族裔和性别对健康结果的影响。 所有DPP参与者，包括那些以前被分配到高强度生活方式、二甲双胍、曲格列酮和安慰剂的人，无论他们在DPP期间是否患上糖尿病，都有资格并将被邀请加入DPPOS。根据民进党队列的基线特征，研究人群的平均年龄将为55岁，其中67%是女性。54%是高加索人，20%是非洲裔美国人，16%是西班牙裔美国人，4%是亚洲或太平洋岛民美国人，5%是美国印第安人。在过去的4-6年中，大约有750名参与者被诊断患有糖尿病。 研究干预：在DPPOS期间，将为所有参与者举行季度小组会议。这些课程将集中在生活方式讲座以及IGT或糖尿病参与者感兴趣的其他话题上。将向最初被分配到强化生活方式干预的小组提供额外的团体生活方式促进会议，并将继续向最初被分配到二甲双胍的参与者提供开放标签二甲双胍治疗(每天两次，850毫克)。 结果：糖尿病的结果与DPP期间的主要结果相同，即根据美国糖尿病协会的标准发展为糖尿病(75克口服葡萄糖试验后，空腹血糖126 mg/dL[7.0 mm ol/L]或2小时血糖200 mg/dL[11.1 mm o l/L]，并经重复试验证实)。 与糖尿病相关的综合结果定义为： A.微血管：包括有以下一种或多种情况：发生视网膜照片发现的糖尿病的任何视网膜病变特征，密歇根神经病变筛查指数(MNSI)得分2，出现蛋白尿(30毫克/克肌酐)，或肾功能障碍(终末期肾脏疾病或肌酐2毫克/分升)；以及 B.大血管：包括有以下一种或多种情况：心血管疾病(CVD)事件(致命性和非致命性心肌梗死和中风)，心电图无症状心肌梗死，冠状动脉造影术记录到的冠状动脉狭窄50%，冠状动脉血运重建，颈动脉超声测量的内中膜厚度绝对值或变化，ICA或CCA等于或超过根据最新研究已知的临床相关值，或脚踝与臂部血压比0.9。 次要结果是： A.糖尿病视网膜病变 B.失明 C.糖尿病神经病变 D.蛋白尿 E.肾功能衰竭 F.心血管疾病事件 G.亚临床动脉粥样硬化结果 H.心血管疾病的风险因素，包括风险概况

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The long-term follow-up study of the DPP, entitled the Diabetes Prevention Program Outcomes Study or DPPOS, is designed to take further advantage of the scientifically and clinically valuable cohort of DPP volunteers and the large volume of data collected during the study to address the issues above. The highly complaint DPP cohort, including 45% minorities, is the largest IGT population ever studied. Moreover, the large number of new onset Type 2 diabetic patients, carefully followed from near the time of their true onset, provides an unparalleled opportunity to study the clinical course of Type 2 diabetes. Objectives: The primary objective of the DPPOS is to evaluate the long-term effects of active DPP interventions on the development of a) diabetes during a further 5-10 years of follow-up and b) composite diabetes-related microangiopathic and cardiovascular disease outcomes. The hypotheses being tested are that both the continued lifestyle intervention and metformin will provide continued separation in the rates of diabetes development, compared with the former placebo group, and that the prevention or delay of diabetes during the DPP and DPPOS will translate into reduced rates of composite outcomes and improved health status. The secondary objectives of the DPPOS are to evaluate the long-term effects of DPP interventions on selected individual health outcomes, the established and putative risk factors for those outcomes, and the costs and cost-utility associated with delay or prevention of diabetes. Other research objectives include examining and comparing the incidence and determinants of these health outcomes in participants with new-onset diabetes and IGT, as well as assessing subgroups of participants in order to evaluate the effect of race/ethnicity and gender on health outcomes. All DPP participants, including those previously assigned to intensive lifestyle, metformin, troglitazone, and placebo, whether or not they developed diabetes during the DPP, are eligible and will be invited to join DPPOS. Based on the baseline characteristics of the DPP cohort, the mean age of the study population will be 55 years, with 67% being women. Fifty-four percent are Caucasian, 20% African-American, 16% Hispanic American, 4% Asian or Pacific Islander-American, and 5% American Indian. Approximately 750 participants will have been diagnosed as having diabetes during the previous 4-6 years. Study Interventions: During DPPOS, quarterly group meetings will be held for all participants. These will focus on lifestyle lectures as well as other topics of interest in participants with IGT or diabetes. Additional group lifestyle booster sessions will be offered to the group originally assigned to intensive lifestyle intervention and open label metformin therapy (850 mg twice per day) will continue to be provided to the participants originally assigned to metformin. Outcomes: The diabetes outcome is the same as the primary outcome during the DPP, i.e. development of diabetes according to American Diabetes Association criteria (fasting plasma glucose level 126 mg/dL [7.0 mmol/L] or 2-hour plasma glucose 200 mg/dL [11.1 mmol/L], after a 75 gram OGTT and confirmed with a repeat test). The composite diabetes-related outcomes are defined as: a. Microvascular: including having one or more of the following: development of any retinopathy characteristic of diabetes detected by retinal photographs, a score 2 on the Michigan Neuropathy Screening Index (MNSI), the development of albuminuria (30 mg/gram creatinine), or renal dysfunction (end-stage renal disease or creatinine 2 mg/dL); and b. Macrovascular: Including having one or more of the following: cardiovascular disease (CVD) events (fatal and non-fatal myocardial infarction and stoke), silent MI on EKG, coronary artery stenosis 50% documented by angiography, coronary revascularization, absolute value of or change in carotid ultrasound measured intimal-medial thickness, either ICA or CCA, that equals or exceeds a value known to be clinical relevant based on emerging research, or an ankle: brachial blood pressure ratio 0.9. Secondary outcomes are: a. Diabetic retinopathy b. Loss of vision c. Diabetic neuropathy d. Albuminuria e. Renal failure f. Cardiovascular disease events g. Subclinical atherosclerosis outcomes h. Risk factors for cardiovascular disease, including risk profiles