Epidemiology of Diabetes Interventions and Complications Data Coordinating Center

糖尿病流行病学干预和并发症数据协调中心

基本信息

批准号：
8439460
负责人：
JOHN M LACHIN
金额：
$ 353.54万
依托单位：
GEORGE WASHINGTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-08-15 至 2017-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8439460
关键词：
Adopted Adverse effects Albuminuria Ancillary Study Biological Markers Blood Vessels Cardiac Cardiovascular Diseases Cardiovascular system Caring Cessation of life Clinical Collaborations Complications of Diabetes Mellitus Coronary artery Data Coordinating Center Data Set Diabetes Mellitus Diabetic Angiopathies Disease Outcome Epidemiology Evaluation Event Eye Fatty acid glycerol esters Frequencies Funding Future Future Generations Genetic Genotype Glucose Glycosylated hemoglobin A Goals Haptoglobins Health Care Costs Hyperglycemia Inflammation Insulin-Dependent Diabetes Mellitus Intervention Kidney Kidney Diseases Knowledge Lead Life Expectancy Lipids Long-Term Effects Magnetic Resonance Imaging Measurement Memory Metabolic Methods Morbidity - disease rate Neurocognition Neuropathy Observational Study Outcome Oxidative Stress Patients Pericardial body location Phase Pilot Projects Play Prevalence Primary Prevention Quality of life Randomized Reading Recording of previous events Research Research Personnel Research Project Grants Residual state Retinal Retinal Diseases Risk Risk Factors Role Sampling Time Variant X-Ray Computed Tomography adjudicate cardiovascular disorder risk cohort conventional therapy diabetes control economic impact follow-up health economics insulin secretion macroalbuminuria mortality novel population based

项目摘要

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. Notably, 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 accurately describe 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 and nephropathy; 5) assess effects of diurnal glycemic variation on complications; and 6) conduct eight new research projects involving new measurements and analyses. PUBLIC HEALTH RELEVANCE: Patients with T1DM (1,500,000 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/EDIC is continuing to describe the long term benefits of intensive therapy on increasingly more severe manifestations of these complications, and to explore the mechanisms by which hyperglycemia and non-glycemic factors lead to an increased risk of these adverse complications, potentially affording a future lifetime free of complications and normal life expectancy for future generations.

描述（由申请人提供）：糖尿病控制和并发症试验（DCCT，1983-1993）在 1441 名 1 型糖尿病 (T1DM) 受试者中比较了旨在接近正常血糖的强化治疗与没有特定血糖目标的常规治疗。 1993 年，经过平均 6.5 年的随访，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%，而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；并预测了终生健康经济影响。 DCCT 强化治疗随后在世界范围内被采用作为 T1DM 的护理标准。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% 的幸存者积极参与。大多数结果每年进行一次评估。 CVD 事件和死亡均经过仔细记录和裁决。 EDIC 值得注意地发现，尽管两组在 EDIC 期间的 HbA1c 水平相似（称为代谢记忆），但强化治疗对并发症的早期有益效果持续了 10 多年。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 合作者还进行了大量辅助研究，并获得了单独的资助，最近包括通过心脏 MRI 测量心脏功能，以及测量作为并发症决定因素的氧化应激和炎症生物标志物。未来 5 年的总体目标是追踪至少 90% 的幸存者；准确描述血糖 (HbA1c) 和其他已确定的和推定的危险因素对糖尿病并发症的长期研究影响以及先前 DCCT 强化治疗的代谢记忆效应；通过支持新研究经费申请的合作来扩展有关 T1DM 及其并发症的知识，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。具体的科学目标是1）评估危险因素、生物标志物和血糖对临床CVD风险的影响； 2）评估CVD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和肾病的危险因素； 5) 评估每日血糖变化对并发症的影响； 6) 开展八个涉及新测量和分析的新研究项目。公共卫生相关性：T1DM 患者（美国有 1,500,000 名）面临微血管和心血管并发症的风险，这是发病率、死亡率和医疗费用的主要原因。 DCCT/EDIC 正在继续描述强化治疗对这些并发症日益严重的表现的长期益处，并探索高血糖和非血糖因素导致这些不良并发症风险增加的机制，可能提供未来一生没有并发症，子孙后代的预期寿命正常。