SEARCH For Diabetes in Youth, Phase 3: Cohort Study-Carolina Center

描述（由申请人提供）：青年糖尿病研究是一项正在进行的多中心研究，包含美国有史以来研究的最大和最具种族多样性的青年糖尿病人群。作为对RFA-DP 10 -001组件B的响应，研究队列研究将利用这一独特资源，继续对选定的研究队列参与者进行研究，以实现以下目的：1）评估慢性微血管疾病选定标志物的患病率、发生率和风险因素，（视网膜病变、肾病和自主神经病变）和大血管并发症（2）评估糖尿病急性并发症（包括严重低血糖和糖尿病酮症酸中毒）的发生率和危险因素;（3）监测死亡率;以及4）确定护理障碍、护理质量以及向成人护理的过渡对糖尿病相关健康结果（包括生活质量）的影响程度。在这些目标的覆盖下，我们将重点关注种族/民族和其他社会文化因素以及糖尿病类型的生化方面对糖尿病相关健康结果的影响。该队列研究将对2002年或以后发生的糖尿病事件的糖尿病参与者进行面对面研究访问，糖尿病持续时间> 5年，基线数据已完成（预期n=3699）。在本研究期间，将收集并分析病史、人体测量、生化、生理和调查数据。随着迈尔-戴维斯博士作为PI和国家主席为2012年，正如我们已经做了整个2012年，卡罗莱纳临床中心将提供实质性的科学领导。对于队列研究，我们在糖尿病视网膜病变和糖尿病肾病领域带来了新的领导地位。重要的是，卡罗莱纳人口在目前的研究中心中社会经济地位最低，超过一半的非裔美国青年来自卡罗莱纳中心。此外，有相当一部分患有2型糖尿病的青少年来自该中心。本研究将利用研究人群的规模和种族多样性，通过传统临床糖尿病类型、美国主要种族/种族群体以及采用新方法按病理生理学维度分离传统临床糖尿病类型，确定护理过程和健康结局的差异。因此，该队列研究很有可能对美国所有主要种族的青年糖尿病患者的临床护理和国家公共卫生政策产生重大影响。

DESCRIPTION (provided by applicant): SEARCH for Diabetes in Youth (SEARCH) is an on-going, multi-center study containing the largest and most ethnically diverse population of youth with diabetes ever studied in the US. In response to RFA-DP10-001, Component B, the SEARCH Cohort Study will utilize this unique resource by continuing the study of selected SEARCH participants to address the following Aims: 1) assess the prevalence, incidence, and risk factors for selected markers of chronic microvascular (retinopathy, nephropathy, and autonomic neuropathy) and macrovascular complications (hypertension, arterial stiffness) of diabetes; 2) assess the incidence and risk factors for acute complications of diabetes including serious hypoglycemia and diabetic ketoacidosis ; 3) conduct surveillance of mortality; and 4) determine the degree to which barriers of care, quality of care, and transition to adult care impact diabetes-related health outcomes including quality of life. Overlaid across these Aims, we will focus on the impact of race/ethnicity and other sociocultural factors, and biochemical dimensions of diabetes type, on diabetes-related health outcomes. The SEARCH Cohort Study will conduct an in-person research study visit on SEARCH participants incident in 2002 or later, with duration of diabetes > 5 years and with baseline data completed (expected n=3699). During this study medical history, anthropometric, biochemical, physiologic, and survey data will be collected and analyzed. With the Dr Mayer-Davis as PI and the national chairperson for SEARCH 2, and as we have done throughout SEARCH, the Carolina Clinical Center will provide substantial scientific leadership. For the Cohort Study we bring new leadership in the areas of diabetic retinopathy and diabetic nephropathy. Importantly, the Carolina population comprises the lowest socioeconomic status among the current SEARCH sites, and over half of the African American youth in SEARCH are from the Carolina Center. Additionally, and a substantial proportion of youth with type 2 diabetes are from this Center. This study will exploit the size and ethnic diversity of the study population to identify differences in both processes of care and health outcomes by traditional, clinical diabetes type; by the major race/ethnic groups in the US; and by employing a novel approach to segregate traditional clinical diabetes types by pathophysiologic dimensions. Thus, the SEARCH cohort study has a high likelihood of making a significant impact on the clinical care of youth with diabetes from all the major ethnic groups in the US and on national public health policy.