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

• 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
• 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

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）：糖尿病控制与并发症试验（DCCT，1983- 1993年）比较了针对几乎正常血糖的强化治疗与1441名患有1型糖尿病（T1DM）的1441名受试者中没有特定葡萄糖靶标的强化疗法。在1993年，在平均随访6.5年之后，该研究表明，强化治疗将视网膜病变，肾病和神经病的风险降低了35-76％，而高血糖症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利影响；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；并预测了终生的健康经济影响。然后，全世界将DCCT强化治疗作为T1DM的标准护理。 糖尿病干预措施及其并发症的流行病学（EDIC，1994年至今）是对DCCT队列的观察性随访研究，其中95％的人活跃于积极参与。每年评估大多数结果。 CVD事件和死亡经过仔细的记录和裁决。 EDIC显着地发现，尽管两组的EDIC中的HBA1C水平相似，但强化治疗对并发症的早期有益作用持续了10年，称为代谢记忆。值得注意的是，以前的强化疗法也大大降低了CVD事件的风险。 DCCT/EDIC合作者还进行了大量辅助研究，并具有单独的资金，最近包括在心脏MRI上测量心脏功能，并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。 接下来的5年的总体目标是遵循至少90％的尚存队列的目标；准确地描述血糖（HBA1C）和其他已建立和推定的危险因素对糖尿病并发症以及先前DCCT强化治疗的代谢记忆影响的长期影响；并通过支持新的研究资金应用程序的合作来扩展有关T1DM及其并发症的知识，以最大程度地利用同类，表型数据集以及收集的生物学和遗传样本。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CVD风险的影响； 2）评估CVD风险因素的长期变化； 3）描述DCCT密集型与常规疗法对死亡率的影响； 4）评估严重视网膜病和肾病的危险因素； 5）评估昼夜血糖变异对并发症的影响； 6）进行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1,500,000例）有微血管和心血管并发症的风险，这是发病率，死亡率和医疗保健成本的主要原因。 DCCT/EDIC正在继续描述强化治疗的长期益处在越来越严重的这些并发症的表现上，并探讨了高血糖和非血糖因素的机制，导致这些不良并发症的风险增加，这可能会给未来的并发症和正常的预期生命提供预期的未来生命。