Epidemiology of Diabetes Interventions and Complications (EDIC)
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 1,441
- 主要终点
- 2022-2027 Cycle
研究概览
简要总结
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 current cycle (2022-2027) are 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
2022-2027 Cycle
时间窗: Eyes (Yrs 32-33, 2025-26); Kidney (annually); Nerves (Yrs 29-31, 33-34, 2022-26); CVD events (continuous, adjudicated annually); Physical (Yrs 29-31, 2022-24); Cognitive (Yrs 32-33, 2025-26); Liver (Yrs 29-31, 2022-24); Sleep (Yrs 29-31, 2022-24).
Advanced microvascular complications (retinopathy, kidney disease, neuropathy), major CVD events or early subclinical, changes in physical and cognitive dysfunction, fibrosis and steatosis, obstructive sleep apnea
次要结局
未报告次要终点
