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

描述（由申请人提供）：青少年糖尿病研究 (SEARCH) 是一项正在进行的多中心研究，包含美国有史以来研究的规模最大、种族最多样化的青少年糖尿病人群。为了响应 RFA-DP10-001 的 B 部分，SEARCH 队列研究将利用这一独特的资源，继续对选定的 SEARCH 参与者进行研究，以实现以下目标：1) 评估糖尿病慢性微血管（视网膜病变、肾病和自主神经病变）和大血管并发症（高血压、动脉硬化）选定标志物的患病率、发病率和危险因素； 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) 进行死亡率监测； 4) 确定护理障碍、护理质量和向成人护理过渡对糖尿病相关健康结果（包括生活质量）的影响程度。在这些目标的基础上，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维度对糖尿病相关健康结果的影响。 SEARCH 队列研究将对 2002 年或以后发生的 SEARCH 参与者事件进行现场研究访问，其中糖尿病病程 > 5 年且基线数据已完成（预计 n=3699）。在这项研究中，将收集和分析病史、人体测量、生化、生理和调查数据。由 Mayer-Davis 博士担任 SEARCH 2 的 PI 和全国主席，正如我们在整个 SEARCH 中所做的那样，卡罗莱纳州临床中心将提供实质性的科学领导力。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，卡罗莱纳州人口的社会经济地位是当前 SEARCH 网站中最低的，SEARCH 中超过一半的非裔美国青年来自卡罗莱纳中心。此外，很大一部分患有 2 型糖尿病的青少年来自该中心。这项研究将利用研究人群的规模和种族多样性来确定传统临床糖尿病类型的护理过程和健康结果的差异；美国主要种族/族裔群体；并采用一种新方法根据病理生理学维度来区分传统的临床糖尿病类型。因此，SEARCH 队列研究很可能对美国所有主要种族的青少年糖尿病患者的临床护理以及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.