DIABETES PREVENTION PROGRAM OUTCOMES STUDY (DPPOS)

糖尿病预防计划成果研究 (DPPOS)

• 批准号: 7627489
• 负责人: STEVEN M. HAFFNER
• 金额: $ 3.57万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7627489
• 关键词: Address; African American; Age; Albuminuria; American; American Indians; Ankle; Asians; Atherosclerosis; Blindness; Blood Pressure; Cardiovascular Diseases; Caucasians; Caucasoid Race; Characteristics; Clinical; Computer Retrieval of Information on Scientific Projects Database; Coronary Angiography; Coronary Stenosis; Creatinine; Data; Development; Diabetes Mellitus; Diabetes prevention; Diabetic Neuropathies; Diabetic Retinopathy; Diagnosis; Disease Outcome; Electrocardiogram; End stage renal failure; Ethnic Origin; Event; Fasting; Follow-Up Studies; Functional disorder; Funding; Gender; Glucose; Grant; Group Meetings; Health; Health Status; Hispanic Americans; Hour; Incidence; Individual; Institution; Intervention; Intervention Studies; Kidney; Kidney Failure; Label; Life Style; Long-Term Effects; Measures; Medial; Metformin; Michigan; Minority; Myocardial Infarction; Neuropathy; Non-Insulin-Dependent Diabetes Mellitus; Numbers; OGTT; Outcome; Outcome Study; Pacific Island Americans; Participant; Patients; Placebos; Plasma; Population; Population Study; Prevention; Race; Rate; Research; Research Personnel; Resources; Retinal; Retinal Diseases; Risk; Risk Factors; Score; Screening procedure; Source; Subgroup; Testing; Thick; Time; Translating; Ultrasonography; United States National Institutes of Health; Woman; base; cohort; cost; day; design; diabetes prevention program; diabetic; follow-up; improved; indexing; interest; lectures; lifestyle intervention; troglitazone; volunteer

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

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 DPP的长期随访研究，标题为“糖尿病预防计划结果研究或DPPO”，旨在进一步利用科学和临床上有价值的DPP志愿者队列以及在研究期间收集的大量数据，以解决上述问题。 高度投诉的DPP队列，包括45％的少数民族，是有史以来最大的IGT人群。 此外，从真实发作的临近开始，大量的新发作2型糖尿病患者就为研究2型糖尿病的临床过程提供了无与伦比的机会。 目的：DPPO的主要目标是评估活性DPP干预措施对a）糖尿病发展的长期影响，在另外5 - 10年的随访中，b）复合糖尿病相关的微血管病和心血管疾病结果。 与以前的安慰剂组相比，持续的生活方式干预和二甲双胍的假设是，持续的生活方式干预和二甲双胍都将持续分离糖尿病发育率，并且在DPP和DPPO期间的预防或糖尿病的预防或延迟将转化为复合材料癌症的降低率和改善的健康状况。 DPPO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危险因素以及与延迟或预防糖尿病有关的成本和成本和成本率。 其他研究目标包括检查和比较具有新的糖尿病和IGT参与者中这些健康结果的发生率和决定因素，以及评估参与者的亚组，以评估种族/族裔和性别对健康结果的影响。 所有DPP参与者，包括先前分配给密集生活方式，二甲双胍，troglitazone和安慰剂的参与者，无论他们在DPP期间是否患有糖尿病，都有资格，并将邀请加入DPPOS。 根据DPP队列的基线特征，研究人群的平均年龄将为55年，而女性为67％。 百分之五十四是高加索人，20％的非裔美国人，16％的西班牙裔美国人，4％的亚裔或太平洋岛民 - 美国人和5％的美洲印第安人。 在过去的4 - 6年中，大约有750名参与者将被诊断为患有糖尿病。 研究干预措施：在DPPO期间，将为所有参与者举行季度小组会议。 这些将着重于生活方式讲座以及IGT或糖尿病参与者感兴趣的其他主题。 最初分配给密集的生活方式干预的小组，将继续向最初分配给二甲双胍的参与者提供其他小组生活方式助推器会议（每天两次850 mg）。 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). 复合糖尿病相关的结果定义为： 一个。 微血管：包括具有以下一项或多项：通过视网膜照片检测到的糖尿病的视网膜病特征的发展，在密歇根州神经病筛查指数（MNSI）上的分数2，蛋白尿（30 mg/gram cretinine）的发展，或肾功能障碍（Endal contaginalione）（30 mg/gram cretinine）或Endal功能障碍（Endal nate Factect）（Endal cartage Crestaine疾病/cretcretal systaine 2 mg）和 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基于新兴研究或脚踝：臂血压比0.9的临床相关值已知。 次要结果是： 一个。 糖尿病性视网膜病 b。 视力丧失 c。 糖尿病神经病 d。 蛋白尿 e。 肾衰竭 f。 心血管疾病事件 g。 亚临床动脉粥样硬化结果 h。 心血管疾病的危险因素，包括风险特征