Continuation of Epidemiology of Diabetes Interventions and Complications (EDIC) Study Biostatistics Center

糖尿病干预和并发症流行病学 (EDIC) 研究继续生物统计中心

基本信息

批准号：
9383250
负责人：
JOHN M LACHIN
金额：
$ 329.39万
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 2022-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9383250
关键词：
Address Adopted Adverse effects Affect Affective Age Aging Aging-Related Process American Ancillary Study Angiography Architecture Biological Biometry Blindness Blood Glucose Brain imaging Cardiac Cardiovascular Diseases Cardiovascular system Caring Cessation of life Chronic Kidney Failure Cognition Cognitive Cognitive aging Cohort Studies Complications of Diabetes Mellitus Cost Analysis Data Data Analyses Development Diabetes Mellitus Diabetic Nephropathy Disease Economics Epidemiology Event Eye Factor Analysis Follow-Up Studies Fracture Frequencies Functional disorder Funding General Population Genotype Glean Glucose Glycosylated hemoglobin A Goals Health Health Care Costs Health Insurance Health Services Accessibility Health system Hyperglycemia Hypoglycemia Impaired cognition Impairment Individual Insulin-Dependent Diabetes Mellitus Intention Intervention Investments Kidney Kidney Diseases Kidney Failure Life Literature Longevity Longitudinal Studies Measurement Measures Mediation Memory Metabolic Metabolic Control Microvascular Dysfunction Modeling Modernization Morbidity - disease rate Neurocognition Neuropathy Observational epidemiology Operative Surgical Procedures Outcome Participant Pathway interactions Patients Persons Phenotype Physical Function Population Prevalence Procedures Process Quality of life Randomized Recommendation Recording of previous events Recurrence Research Resources Retinal Retinal Diseases Risk Risk Factors Sampling Seminal Testing adjudicate arm blood glucose regulation bone mass bone quality cardiovascular disorder risk cohort conventional therapy cost effectiveness diabetes control diabetes mellitus therapy disability disorder risk economic impact falls follow-up frailty functional status health economics healthy aging mortality non-diabetic novel screening standard of care tomography treatment group vector

项目摘要

Project Summary 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) over a mean follow-up of 6.5 yrs. Intensive therapy reduced the risks of retinopathy, nephropathy, and neuropathy by 35-76%, hyperglycemia being 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 94% of those surviving actively participating. Participants are evaluated annually. CVD events and deaths are carefully documented and adjudicated. EDIC has notably shown that the early beneficial effects of intensive versus conventional therapy on complications have persisted for more than 15 years despite the similar HbA1c levels in the two groups during EDIC, termed metabolic memory. Former intensive therapy also greatly reduced the risk of CVD events, advanced microvascular complications, such as chronic kidney disease and eye complications requiring surgery, and mortality. DCCT/EDIC collaborators have also conducted numerous ancillary studies with separate funding. The overarching goals for the next 5 years (2017-22) will be to take advantage of the loyal and highly characterized DCCT/EDIC cohort and study the occurrence of physical and cognitive dysfunction and more advanced complications, and their risk factors, in this aging type 1 diabetes population. Since current-day diabetes therapy has increased the longevity of people with type 1 diabetes, it is critical to understand how aging affects patients with type 1 diabetes and to define the risk factors for the occurrence of aging sensitive deficits. In addition, the accrual of long-term severe complications will allow the study of their risk factors and the quality-of-life and health economic consequences. The specific scientific aims are to 1) examine the prevalence of cognitive, affective, and physical impairments in T1DM, and the association of DCCT treatment arm, glycemia, and established and putative non-glycemic risk factors on important domains of aging: cognitive, affective and physical impairments, functional limitations, disability, quality-of-life, frailty, falls, fractures, and survival; 2) analyze the risk factors/mechanisms associated with severe/advanced microvascular complications; 3) analyze the risk factors/mechanisms associated with CVD and mortality; 4) develop new research approaches to measure the progression of diabetes outcomes (vectors) in T1DM, derived from the unique long-term, longitudinal follow-up of the DCCT cohort; and 5) study the long-term economic consequences of T1DM.

项目概要糖尿病控制和并发症试验（DCCT，1983-1993）比较了强化治疗，旨在 1441 名 1 型糖尿病患者的血糖接近正常，与没有特定血糖目标的常规疗法相比平均随访 6.5 年，发现糖尿病 (T1DM)。强化治疗降低了视网膜病变的风险，肾病和神经病的发生率高达 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的影响（CVD）危险因素、神经认知和生活质量；并预测了终生健康经济影响。 DCCT 随后，强化治疗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，94% 的幸存者积极参与。每年对参与者进行评估。 CVD 事件和死亡均经过仔细记录和裁决。 EDIC 值得注意的是，强化治疗与常规治疗相比对并发症的早期有益效果尽管 EDIC 期间两组的 HbA1c 水平相似，但这种情况持续了 15 年以上，称为代谢记忆。以前的强化治疗也大大降低了CVD事件的风险，晚期微血管并发症，例如慢性肾病和需要手术的眼部并发症，以及死亡。 DCCT/EDIC 合作者还利用单独的资金进行了大量辅助研究。未来 5 年（2017-22 年）的总体目标将是利用忠诚度高的员工表征 DCCT/EDIC 队列并研究身体和认知功能障碍的发生等在这一老龄化的 1 型糖尿病人群中，晚期并发症及其危险因素。自今日起糖尿病治疗延长了 1 型糖尿病患者的寿命，了解如何延长其寿命至关重要衰老对 1 型糖尿病患者的影响并确定衰老敏感发生的危险因素赤字。此外，长期严重并发症的发生将有助于研究其危险因素和生活质量和健康经济后果。具体的科学目标是 1) 检查认知、情感和身体的普遍程度 T1DM 损伤以及 DCCT 治疗组、血糖以及已建立和推定的相关性衰老重要领域的非血糖风险因素：认知、情感和身体损伤，功能限制、残疾、生活质量、虚弱、跌倒、骨折和生存； 2）分析风险与严重/晚期微血管并发症相关的因素/机制； 3）分析风险与CVD和死亡率相关的因素/机制； 4）开发新的研究方法来衡量 T1DM 中糖尿病结局（向量）的进展，源自独特的长期纵向随访 DCCT 队列的； 5) 研究 T1DM 的长期经济后果。