Limited Competition for the Continuation of Epidemiology of Diabetes Interventions and Complications (EDIC) Study Clinical Research Center (Collaborative U01)

糖尿病干预和并发症流行病学 (EDIC) 研究临床研究中心（合作 U01）继续有限竞争

• 批准号: 9557690
• 负责人: Rose A Gubitosi-Klug
• 金额: $ 33.43万
• 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 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9557690
• 关键词: Address; Adopted; Adverse effects; Affect; Affective; Age; Aging; Aging-Related Process; American; Ancillary Study; Angiography; Architecture; Biological; Blindness; Blood Glucose; Brain imaging; Cardiac; Cardiovascular Diseases; Cardiovascular system; Caring; Cessation of life; Chronic Kidney Failure; Clinical Research; 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

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.

项目摘要 糖尿病控制和并发症试验（DCCT，1983-1993）比较了强化治疗， 在1441例1型糖尿病受试者中，接近正常的血糖水平与无特定血糖目标的常规治疗相比 糖尿病（T1 DM）的平均随访时间为6.5年。强化治疗降低了视网膜病变的风险， 肾病和神经病的发病率为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不良反应;评估了其对心血管疾病的影响 (CVD)风险因素，神经认知和生活质量;并预测了终身健康经济影响。DCCT 强化治疗随后在全球范围内被采用作为T1 DM的标准治疗。 糖尿病干预措施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%的存活者积极参与。 每年对参与者进行评估。CVD事件和死亡被仔细记录和裁定。EDIC 已经明显表明，与常规治疗相比，强化治疗对并发症的早期有益效果 尽管EDIC期间两组的HbA 1c水平相似，但持续了15年以上， 代谢记忆以前的强化治疗也大大降低了心血管事件的风险， 微血管并发症，如需要手术的慢性肾病和眼部并发症，以及 mortality. DCCT/EDIC合作者还进行了许多辅助研究，并单独提供资金。 未来5年（2017-22）的总体目标将是利用忠诚和高度 描述DCCT/EDIC队列，研究身体和认知功能障碍的发生率， 晚期并发症及其危险因素。从今天起 糖尿病治疗增加了1型糖尿病患者的寿命，关键是要了解如何 衰老对1型糖尿病患者的影响，并明确发生衰老敏感的危险因素 赤字此外，长期严重并发症的增加将允许研究其风险因素， 生活质量和健康的经济后果。 具体的科学目标是：1）检查认知，情感和身体疾病的患病率 T1 DM中的损害，以及DCCT治疗组、糖尿病和已确定的和假定的 非血糖风险因素对衰老的重要领域：认知，情感和身体障碍， 功能限制、残疾、生活质量、虚弱、福尔斯、骨折和生存; 2）分析风险 与重度/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测量 T1 DM患者的糖尿病结局进展（向量），来自独特的长期纵向随访 DCCT队列;和5）研究T1 DM的长期经济后果。