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

描述（由申请人提供）：SEARCH for Diabetes in Youth （SEARCH）是一项正在进行的、多中心的研究，包含了在美国研究过的规模最大、种族最多样化的青少年糖尿病患者。为了响应RFA-DP10-001， 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、动脉僵硬）的选定标志物的患病率、发病率和危险因素；2)评估严重低血糖、糖尿病酮症酸中毒等糖尿病急性并发症的发生率及危险因素；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局（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的影响，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。SEARCH队列研究将对2002年或之后发生糖尿病的SEARCH参与者进行亲自研究访问，这些参与者的糖尿病病程为50年，基线数据已完成（预计n=3699）。在本研究期间，将收集和分析病史、人体测量、生化、生理和调查数据。迈尔-戴维斯博士担任PI和SEARCH 2的全国主席，正如我们在整个SEARCH中所做的那样，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。重要的是，在目前的搜索站点中，卡罗来纳人口的社会经济地位是最低的，而且超过一半的非裔美国青年在搜索中来自卡罗来纳中心。此外，有相当比例的青少年2型糖尿病患者来自该中心。本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在护理过程和健康结果方面的差异；美国主要种族/族裔群体；并采用一种新颖的方法，通过病理生理维度来区分传统的临床糖尿病类型。因此，SEARCH队列研究极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.