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

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局的影响。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。俄亥俄州研究中心将与其他临床试验机构合作，从所有合格病例中收集本提案中描述的数据。我们预计约有646例俄亥俄州受试者有资格参加研究。对于2002-2005年事件病例，85%的俄亥俄州参与者至少返回接受了一次随访访视，这是研究范围内最高的应答率。俄亥俄州团队的实验室岩心样本完整率也是最高的。对于事件2006例，俄亥俄州的完整性为99%，事件2008例的完整性为100%。在本提案中，俄亥俄州研究中心将采用与研究1和2相同的方法和技术，以保持较高的受试者保留率。因此，俄亥俄州研究中心很有可能达到本提案中的招募目标，这将显著促进研究中心队列研究的成功。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 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.