DIABETES PREVENTION PROGRAM OUTCOMES STUDY (DPPOS)

糖尿病预防计划成果研究 (DPPOS)

• 批准号: 7718695
• 负责人: STEVEN M. HAFFNER
• 金额: $ 0.5万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718695
• 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

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 DPP的长期随访研究名为糖尿病预防计划结局研究（DPPOS），旨在进一步利用具有科学和临床价值的DPP志愿者队列以及研究期间收集的大量数据来解决上述问题。 高投诉DPP队列，包括45%的少数民族，是有史以来研究的最大IGT人群。 此外，大量新发2型糖尿病患者，从接近其真正发病的时间开始仔细跟踪，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：DPPOS的主要目的是评价积极DPP干预对a）未来5-10年随访期间糖尿病和B）复合糖尿病相关微血管病变和心血管疾病结局发展的长期影响。 正在测试的假设是，与之前的安慰剂组相比，持续的生活方式干预和二甲双胍将在糖尿病发展率方面提供持续的分离，并且DPP和DPPOS期间预防或延迟糖尿病将转化为复合结局的发生率降低和健康状况改善。 DPPOS的次要目的是评价DPP干预对选定的个人健康结局的长期影响，这些结局的既定和推定风险因素，以及与延迟或预防糖尿病相关的成本和成本效用。 其他研究目标包括检查和比较新发糖尿病和IGT参与者中这些健康结局的发生率和决定因素，以及评估参与者亚组，以评估种族/民族和性别对健康结局的影响。 所有DPP受试者，包括先前分配到强化生活方式、二甲双胍、曲格列酮和安慰剂组的受试者，无论他们是否在DPP期间发生糖尿病，都有资格参加DPPOS。 基于DPP队列的基线特征，研究人群的平均年龄为55岁，其中67%为女性。 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，5%是美洲印第安人。 大约750名参与者将在过去4-6年内被诊断为糖尿病。 研究干预：在DPPOS期间，将为所有参与者举行季度小组会议。 这些将侧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。 将为最初分配接受强化生活方式干预的受试者提供额外的生活方式强化治疗，并将继续为最初分配接受二甲双胍治疗的受试者提供开放标签二甲双胍治疗（850 mg，每日两次）。 成果：糖尿病结局与DPP期间的主要结局相同，即根据美国糖尿病协会标准发生糖尿病（空腹血糖水平126 mg/dL [7.0 mmol/L]或2小时血糖200 mg/dL [11.1 mmol/L]，75 g OGTT后并经重复试验证实）。 复合糖尿病相关结局定义为： a. 微血管：包括具有以下中的一种或多种：通过视网膜照片检测到的糖尿病的任何视网膜病变特征的发展、密歇根神经病筛查指数（MNSI）评分2、白蛋白尿（30 mg/g肌酐）的发展或肾功能障碍（终末期肾病或肌酐2 mg/dL）;以及 B. 大血管： 包括具有以下一项或多项：心血管疾病（CVD）事件（致死性和非致死性心肌梗死和斯托克）、EKG无症状性MI、血管造影证实的冠状动脉狭窄50%、冠状动脉血运重建、颈动脉超声测量的内膜-中层厚度（伊卡或CCA）的绝对值或变化等于或超过基于新兴研究的已知临床相关值，或者脚踝：肱动脉血压比0.9。 次要结局为： a. 糖尿病视网膜病变 B. 视力丧失 C. 糖尿病神经病变 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局 H. 心血管疾病的风险因素，包括风险特征