Epidemiology of Diabetes Interventions and Complications

描述（由申请人提供）：糖尿病控制和并发症试验（DCCT, 1983-1993），随机选取1441例1型糖尿病（T1DM）患者，他们没有或很少存在并发症，接受旨在接近正常血糖的强化治疗或旨在维持临床健康的常规治疗，没有特定的血糖目标。1993年，经过平均6.5年的随访，该研究显示强化治疗的压倒性益处，与常规治疗相比，可将视网膜病变、肾病和神经病变的风险降低35-76%。DCCT还显示高血糖是并发症的主要决定因素，并探讨和描述了强化治疗的特点，包括其对心血管疾病（CVD）危险因素、神经认知和生活质量的影响，以及预计的健康经济影响。DCCT强化治疗随后在世界范围内被采纳为TIDM的标准治疗。这项名为《糖尿病干预及其并发症的流行病学》（EDIC， 1994年至今）的研究是对DCCT的观察性随访研究，采用相同的方法，随访了95%的存活的原始队列。大多数结果每年评估一次，心血管疾病的结果和死亡仔细记录和裁决。EDIC显著地发现，强化治疗对并发症的早期有益效果持续了10年或更长时间，尽管在EDIC期间，前DCCT强化组和常规组的HbA1c水平相似。这种现象被称为“代谢记忆”。值得注意的是，前强化治疗也降低了心血管疾病事件的风险。DCCT/EDIC未来5年的目标是继续艰苦的随访，以确定强化治疗的终身效果，血糖

DESCRIPTION (provided by applicant): The Diabetes Control and Complications Trial (DCCT, 1983-1993), randomized 1441 subjects with type 1 diabetes (T1DM) with no or minimal pre-existing complications to receive either intensive therapy aimed at near normal glycemia or conventional therapy aimed at maintenance of clinical well-being with no specific glucose targets. In 1993, after a mean follow-up of 6.5 yrs, the study showed an overwhelming benefit of intensive therapy that reduced the risks of retinopathy, nephropathy, and neuropathy by 35-76% compared to conventional therapy. The DCCT also showed that hyperglycemia was a primary determinant of complications, explored and described the features of Intensive therapy, including its effects on cardiovascular disease (CVD) risk factors, neurocognition and quality of life, and the projected health economic impact. DCCT intensive therapy was then adopted world-wide as standard-of-care for TIDM. The study, Epidemiology of Diabetes Interventions and its Complications (EDIC, 1994-present), is the observational follow-up study of the DCCT, using the same methods and following 95% of the surviving original cohort. Most outcomes are evaluated annually and CVD outcomes and deaths carefully documented and adjudicated. EDIC has notably discovered that the early beneficial effects of intensive treatment on complications have persisted for 10 years or more, despite the fact that HbA1c levels of the former DCCT intensive and conventional groups have been similar during EDIC. This phenomenon has been termed "metabolic memory." Remarkably, former Intensive therapy also reduced the risk of CVD events. The goals of the DCCT/EDIC for the next 5 years are to continue the assiduous follow-up to establish the life-long effects of intensive therapy, glycemia and other risk factors on diabetes complications, morbidity and mortality; to examine the durability and mechanisms of the metabolic memory phenomenon; describe the rates of progression to severe levels of microvascular complications (vision-threatening retinopathy, end stage renal disease, debilitating neuropathy) and CVD and mortality; perform epidemiologic analyses to investigate further the risk factors (including genetic factors) for diabetes complications across their entire spectrum of severity; determine the lifetime health economic Impact of DCCT intensive therapy based; and through additional funding applications, continue to expand and support investigators who will utilize the cohort, the phenotypic data set, and collected biologic and genetic samples to their greatest effect, expanding the knowledge regarding type 1 diabetes and its complications. PUBLIC HEALTH RELEVANCE: Subjects with diabetes, (1,500,000 insulin-dependent type 1 DM in the US) are at risk of microvascular and cardiovascular complications that are a major cause of morbidity, mortality and health care cost. The DCCT is continuing to demonstrate the long term benefits of near-normal glycemic control and to explore the mechanisms by which hyperglycemia leads to an increased risk of these adverse complications, potentially affording a future lifetime free of complications and a normal life expectancy for future generations.