Epidemiology of Diabetes Interventions and Complications (EDIC)

糖尿病干预和并发症的流行病学 (EDIC)

• 批准号: 9095355
• 负责人: Rose A Gubitosi-Klug
• 金额: $ 484.57万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-30 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9095355
• 关键词: Adopted; Adverse effects; Albuminuria; Ancillary Study; Biological Markers; Blood Vessels; Budgets; Cardiac; Cardiovascular Diseases; Cardiovascular system; Certification; Cessation of life; Clinic; Clinical; Collaborations; Companions; Complications of Diabetes Mellitus; Data; Data Coordinating Center; Data Set; Diabetes Mellitus; Disease Outcome; Electrocardiogram; Ensure; Epidemiology; Evaluation; Event; Funding; Future; Future Generations; Genetic; Glucose; Glycosylated hemoglobin A; Goals; Health; Health Care Costs; Human Resources; Hyperglycemia; Individual; Inflammation; Insulin-Dependent Diabetes Mellitus; Intervention; Kidney; Kidney Diseases; Knowledge; Laboratories; Lead; Life Expectancy; Lipids; Long-Term Effects; Magnetic Resonance Imaging; Measurement; Memory; Metabolic; Methods; Microvascular Dysfunction; Monitor; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Neurocognition; Neuropathy; Observational Study; Outcome; Oxidative Stress; Participant; Patients; Performance; Phase; Play; Policies; Preparation; Primary Prevention; Procedures; Publications; Quality of life; Randomized; Reading; Recording of previous events; Research; Research Personnel; Research Project Grants; Retinal Diseases; Risk; Risk Factors; Role; Sampling; Site; Statistical Methods; Training; Universities; Variant; Washington; Work; adjudicate; cardiovascular disorder risk; clinical risk; cohort; computerized; conventional therapy; cost; data management; design; diabetes control; economic impact; follow-up; health economics; macroalbuminuria; meetings; mortality; novel marker; phenotypic data; sound; standard of care; treatment group

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.

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（T1DM）患者中比较了以接近正常血糖为目标的强化治疗与无特定血糖靶点的常规治疗。1993年，经过平均6.5年的随访，研究得出结论，强化治疗使视网膜病变、肾病和神经病变的风险降低了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副作用；评估其对心血管疾病（CVD）危险因素、神经认知和生活质量的影响；并预测了一生的健康经济影响。DCCT强化治疗随后在世界范围内被采纳为T1DM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）是一项对DCCT队列的观察性随访研究，95%的幸存者积极参与。大多数结果每年评估一次。心血管疾病事件和死亡被仔细记录和裁决。EDIC特别发现，尽管两组患者在EDIC期间HbA1c水平相似，但强化治疗对并发症的早期有益效果持续了10年以上，这被称为代谢记忆。值得注意的是，以前的强化治疗也大大降低了心血管疾病事件的风险。DCCT/EDIC合作者还进行了许多辅助研究，并获得了单独的资助，最近的研究包括在心脏MRI上测量心功能，以及测量氧化应激和炎症的生物标志物作为并发症的决定因素。未来5年的总体目标是追踪至少90%的存活患者；准确描述研究期间血糖（HbA1c）和其他已知的和假定的危险因素对糖尿病并发症的影响，以及既往DCCT强化治疗的代谢记忆效应；并通过支持新的研究基金申请的合作来扩大对T1DM及其并发症的认识，以最大限度地利用队列、表型数据集以及收集的生物和遗传样本。具体的科学目的是：1)评估危险因素、生物标志物和血糖对临床心血管疾病风险的影响；2)评估心血管疾病危险因素的长期变化；3)描述DCCT强化治疗与常规治疗对死亡率的影响；4)评估严重视网膜病变/肾病的危险因素；5)评估血糖日变化对并发症的影响；6)开展八个新的研究项目，包括新的测量和分析。