Epidemiology of Diabetes Interventions and Complications (EDIC)

描述（由申请人提供）：糖尿病控制和并发症试验（DCCT，1983-1993）在1441例1型糖尿病（T1 DM）受试者中比较了旨在接近正常血糖的强化治疗与无特定血糖目标的常规治疗。1993年，经过平均6.5年的随访，该研究最终表明，强化治疗可将视网膜病变、肾病和神经病变的风险降低35- 76%，高血糖是并发症的主要决定因素。我们还描述了强化治疗的潜在不良反应;评估了其对心血管疾病（CVD）危险因素，神经认知和生活质量的影响;并预测了终身健康经济影响。DCCT强化治疗随后在全球范围内被采用作为T1 DM的标准治疗。 糖尿病干预及其并发症的流行病学（EDIC，1994年至今）是DCCT队列的观察性随访研究，95%的存活者积极参与。大多数成果每年进行评估。CVD事件和死亡被仔细记录和裁定。EDIC特别发现，尽管两组EDIC期间的HbA 1c水平相似，但强化治疗对并发症的早期有益影响持续了10多年，称为代谢记忆。值得注意的是，以前的强化治疗也大大降低了CVD事件的风险。DCCT/EDIC合作者还进行了许多辅助研究，单独提供资金，最近包括在心脏MRI上测量心脏功能以及测量氧化应激和炎症生物标志物作为并发症的决定因素。 未来5年的总体目标是随访至少90%的存活队列;准确描述HbA 1c和其他已确定和推定的风险因素对糖尿病并发症的长期影响以及既往DCCT强化治疗的代谢记忆效应;并通过支持新研究资金申请的合作来扩大关于T1 DM及其并发症的知识，以最大限度地利用队列，表型数据集和收集的生物和遗传样本。 具体的科学目的是：1）评价风险因素、生物标志物和血糖对临床CVD风险的影响; 2）评估CVD风险因素的长期变化; 3）描述DCCT强化治疗与常规治疗对死亡率的影响; 4）评价重度视网膜病变/肾病的风险因素; 5）评估昼夜血糖变化对并发症的影响;（六）开展八项新的研究项目，包括新的测量和分析方法。

DESCRIPTION (provided by applicant): The Diabetes Control and Complications Trial (DCCT, 1983-1993) compared intensive therapy aimed at near normal glycemia versus conventional therapy with no specific glucose targets in 1441 subjects with type 1 diabetes (T1DM). In 1993, after a mean follow-up of 6.5 yrs, the study showed conclusively that intensive therapy reduced the risks of retinopathy, nephropathy, and neuropathy by 35-76%, and that hyperglycemia was a primary determinant of complications. We also described potential adverse effects of intensive therapy; assessed its effects on cardiovascular disease (CVD) risk factors, neurocognition and quality of life; and projected the lifetime health-economic impact. DCCT intensive therapy was then adopted world- wide as standard-of-care for T1DM. The Epidemiology of Diabetes Interventions and its Complications (EDIC, 1994-present) is the observational follow-up study of the DCCT cohort, with 95% of those surviving actively participating. Most outcomes are evaluated annually. CVD events and deaths are carefully documented and adjudicated. EDIC has notably discovered that the early beneficial effects of intensive treatment on complications have persisted for over 10 years despite the similar HbA1c levels during EDIC in the two groups, termed metabolic memory. Remarkably, former intensive therapy also greatly reduced the risk of CVD events. DCCT/EDIC collaborators have also conducted numerous ancillary studies, with separate funding, most recently including measurement of cardiac function on cardiac MRI and measurement of biomarkers of oxidative stress and inflammation as determinants of complications. The overarching goals for the next 5 years are to follow at least 90% of the surviving cohort; to describe accurately the study-long effects of glycemia (HbA1c) and other established and putative risk factors on diabetes complications and the metabolic memory effects of prior DCCT intensive therapy; and to expand knowledge regarding T1DM and its complications by supporting collaborations for new research funding applications to maximally utilize the cohort, phenotypic data set, and collected biologic and genetic samples. The specific scientific aims are to 1) evaluate effects of risk factors, biomarkers and glycemia on risk of clinical CVD; 2) assess the long-term changes in CVD risk factors; 3) describe effects of DCCT intensive versus conventional therapy on mortality; 4) evaluate risk factors for severe retinopathy/nephropathy; 5) assess effects of diurnal glycemic variation on complications; and 6) conduct eight new research projects involving new measurements and analyses.