Epidemiology of Diabetes Interventions and Complications (EDIC) Study

糖尿病干预和并发症 (EDIC) 流行病学研究

基本信息

批准号：
10532512
负责人：
Ionut Bebu
金额：
$ 650万
依托单位：
CASE WESTERN RESERVE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-22 至 2027-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10532512
关键词：
Activities of Daily Living Address Adopted Advanced Development Adverse effects Affect Age Aging American Amputation Anatomy Angiography Attention Autonomic Dysfunction Biological Markers Blindness Blood Vessels Canada Cardiac Cardiopulmonary Cardiovascular Diseases Cardiovascular system Caring Clinical Clinical Treatment Clinical Trials Cognitive Cohort Studies Community Trial Complications of Diabetes Mellitus Development Diabetes Mellitus Disease Outcome Echocardiography Epidemiology Epigenetic Process Esthesia Event Exercise Exercise Test Exposure to Eye Fibrosis Follow-Up Studies Functional Imaging Functional disorder Funding Generations Genetic Glucose Glycosylated hemoglobin A Goals Health Care Costs Heart Diseases Heart failure Heterogeneity Hyperglycemia Impaired cognition Impairment Incidence Individual Inflammation Insulin-Dependent Diabetes Mellitus Intervention Kidney Kidney Diseases Kidney Failure Kinetics Knowledge Lead Liver Liver diseases Longevity Longitudinal cohort study Lung Measurement Measures Mediation Memory Metabolic Methods Microvascular Dysfunction Morbidity - disease rate Myocardial Nerve Neurocognition Neuropathy Non-Insulin-Dependent Diabetes Mellitus North America Obesity Observational Study Obstructive Sleep Apnea Optical Coherence Tomography Organ Outcome Overweight Oxygen Participant Pathway interactions Patients Pattern Performance Phenotype Physical Function Population Prevalence Quality of life Questionnaires Randomized Recording of previous events Reporting Resistance Retina Retinal Diseases Risk Risk Factors Self Management Severity of illness Sleep Apnea Syndromes Standardization Steatohepatitis Stress Subgroup Suggestion Symptoms Time Ulcer Vital Status Weight Gain adjudicate adverse outcome arterial stiffness base cardiovascular disorder risk cognitive function cohort community based care comorbidity conventional therapy cost diabetes control diabetes management economic impact economic outcome effective intervention exercise intolerance experience fatty liver disease fitness follow-up frailty health assessment health economics high risk improved indexing innovation lens liver stiffness macrovascular disease modifiable risk mortality non-alcoholic fatty liver disease non-diabetic novel obese person painful neuropathy public health priorities response skeletal sleep abnormalities standard of care study population tonometry trial comparing uptake

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 years. Intensive therapy reduced the risks of retinopathy, nephropathy, and neuropathy by 35-76%. The level of glycemia was the primary determinant of complications. We also described the 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. After the primary DCCT results were reported in 1993, intensive therapy aiming for a HbA1c <7% was adopted world-wide as standard-of-care for T1DM. The Epidemiology of Diabetes Interventions and Complications (EDIC, 1994-present) is the observational follow-up study of the DCCT cohort. Micro- and cardio-vascular complications and a wide range of established and putative risk factors, including genetic and epigenetic factors, have been measured with standardized methods, carefully documented and events adjudicated. EDIC has notably shown that the early beneficial effects of intensive versus conventional therapy on complications persisted for ~15 years despite the convergence of HbA1c levels in the two groups during EDIC, a novel concept termed metabolic memory. Prior intensive therapy was also shown to reduce substantially the risk of CVD events and mortality. The overarching goals for the next 5 years (2022-27) will be to study the occurrence and identify potentially modifiable risk factors of the more advanced microvascular and cardiovascular complications and physical and cognitive dysfunction that are occurring with increasing diabetes duration and age. With increasing longevity, the increased adiposity that has affected patients with T1DM, including EDIC participants, has potential adverse consequences. Thus, the impact of diabetes duration, aging and adiposity on morbidities and their underlying risk factors will be studied. The results will guide treatment priorities as T1DM patients age. The specific aims for 2022-2027 are to: 1) determine the incidence of advanced microvascular complications, investigate the order of their development and pattern of co-development, and identify glycemic and non-glycemic risk factors; 2) quantify impairment in functional and myocardial performance that presages heart failure (HF) and identify the risk factors for impairment in T1DM; 3) determine the prevalence of Non-Alcoholic Fatty Liver Disease (NAFLD) and steatohepatitis-associated fibrosis (NASH) and symptoms suggestive of obstructive sleep apnea (OSA) in this increasingly overweight/obese T1DM study population and identify precedent risk factors and mechanisms; and 4) continue the longitudinal assessment of aging-sensitive morbidities such as cognitive and physical dysfunction, frailty, and their risk factors and their aggregate impact on quality of life, ability to self-manage T1DM, and health economic outcomes.

项目概要糖尿病控制和并发症试验（DCCT，1983-1993）比较了旨在接近正常的强化治疗 1441 名 1 型糖尿病 (T1DM) 受试者的血糖与无特定血糖目标的常规疗法的比较平均随访时间为 6.5 年。强化治疗可将视网膜病、肾病和神经病的风险降低 35-76%。血糖水平是并发症的主要决定因素。我们还描述了强化的不利影响治疗;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；并预计终生健康经济影响。 1993 年报告初步 DCCT 结果后，针对 HbA1c <7% 被全球范围内采用作为 T1DM 的治疗标准。糖尿病干预和并发症的流行病学（EDIC，1994 年至今）是观察性随访 DCCT 队列研究。微血管和心血管并发症以及各种已确定和推定的风险因素，包括遗传和表观遗传因素，已通过标准化方法进行测量，并仔细记录和记录裁决的事件。 EDIC 已显着表明，强化治疗与常规治疗相比对早期的有益效果尽管 EDIC 期间两组 HbA1c 水平趋同，但并发症持续了约 15 年。称为代谢记忆的概念。先前的强化治疗也被证明可以大大降低 CVD 事件的风险和死亡率。未来 5 年（2022-27 年）的总体目标将是研究该事件的发生并确定潜在的可修改方案更严重的微血管和心血管并发症以及身体和认知功能障碍的危险因素随着糖尿病病程和年龄的增加而发生。随着寿命的延长，肥胖也随之增加受影响的 T1DM 患者（包括 EDIC 参与者）具有潜在的不良后果。因此，糖尿病的影响将研究持续时间、衰老和肥胖对发病及其潜在危险因素的影响。结果将指导治疗随着 T1DM 患者年龄的增长，优先考虑的事项。 2022-2027 年的具体目标是：1) 确定晚期微血管并发症的发生率，研究它们的发展顺序和共同发展模式，并识别血糖和非血糖风险因素； 2) 量化预示心力衰竭 (HF) 的功能和心肌性能损伤，并确定 T1DM 受损的危险因素； 3) 确定非酒精性脂肪肝病 (NAFLD) 的患病率以及脂肪性肝炎相关纤维化 (NASH) 和提示阻塞性睡眠呼吸暂停 (OSA) 的症状日益增多超重/肥胖 T1DM 研究人群并确定先例风险因素和机制； 4) 继续对衰老敏感疾病的纵向评估，例如认知和身体功能障碍、虚弱及其风险因素及其对生活质量、自我管理 T1DM 能力和健康经济成果的总体影响。