SEARCH 3 Cohort Study to Assess Incidence of Acute and Chronic Diabetes-related C

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。在这些目标之上，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。俄亥俄站点将与其他SEARCH临床中心合作，从所有符合条件的病例中收集本提案中描述的数据。我们预计约有646名俄亥俄州受试者将有资格参加。对于2002-2005年的事件，俄亥俄州85%的参与者至少进行了一次随访，这是研究范围内最高的回复率。俄亥俄小组的实验室岩心样本的完成率也最高。对于2006年事件，俄亥俄州的完整性为99%，2008年事件的完整性为100%。在这个建议中，俄亥俄站点将采用与SEARCH 1和2相同的方法和技术来保持较高的主题保留率。因此，俄亥俄站点非常有可能满足本提案中的招募目标，这对SEARCH队列研究的成功做出了重大贡献。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 socio-cultural 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. In collaboration with the other SEARCH clinical centers, the Ohio site will collect the data described in this proposal from all eligible cases. We expect approximately 646 Ohio subjects will be eligible to participate. For Incident 2002-2005 cases, 85% of the Ohio participants have returned for at least one follow-up visit, which is the highest study-wide response rate. The Ohio team also has the highest rate for completeness of laboratory core samples. For Incident 2006 cases, Ohio had 99% completeness, and 100% completeness for Incident 2008 cases. In this proposal the Ohio site will employ the same approach and techniques used in SEARCH 1 and 2 to maintain high subject retention rates. Thus, the Ohio site has a very high likelihood of meeting the recruitment goals in this proposal contributing significantly to the success of the SEARCH Cohort Study. 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.