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

描述(由申请者提供)：搜索青年糖尿病(SEARCH)是一项正在进行的多中心研究，包含了美国有史以来研究过的最大规模和最具种族多样性的青年糖尿病人群。针对RFA-DP10-001，B部分，搜索队列研究将利用这一独特资源，继续对选定的搜索参与者进行研究，以达到下列目标：1)评估糖尿病慢性微血管病变(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)的特定标记物的患病率、发病率和风险因素；2)评估糖尿病急性并发症的发病率和风险因素，包括严重的低血糖和糖尿病酮症酸中毒；3)对死亡率进行监测；以及4)确定护理障碍、护理质量和过渡到成人护理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，以及糖尿病类型的生物化学方面对糖尿病相关健康结果的影响。搜索队列研究将对2002年或以后的搜索参与者进行面对面的研究访问，访问时间为5年，并完成基线数据(预计n=3699)。在这项研究中，将收集和分析医学史、人体测量学、生化、生理学和调查数据。在与其他搜索临床中心的合作下，俄亥俄州的网站将从所有符合条件的病例中收集本提案中描述的数据。我们预计大约有646名俄亥俄州的受试者有资格参加。对于2002-2005年的事件，85%的俄亥俄州参与者已返回至少一次后续访问，这是整个研究范围内最高的响应率。俄亥俄州的团队也拥有最高的实验室岩心样本完成率。对于2006年的事件案例，俄亥俄州的完成率为99%，而对于2008年的事件案例，完成率为100%。在这项提议中，俄亥俄州的网站将采用与搜索1和搜索2相同的方法和技术，以保持较高的主题保留率。因此，俄亥俄州的网站很有可能达到这项提案中的招聘目标，这对搜索队列研究的成功做出了重大贡献。这项研究将利用研究人群的规模和种族多样性，根据传统的临床糖尿病类型、美国的主要种族/民族以及采用一种新的方法按病理生理维度区分传统的临床糖尿病类型，来确定护理过程和健康结果的差异。因此，SEARCH队列研究很有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.