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临床试验/NCT00360893
NCT00360893进行中(未招募)不适用

Epidemiology of Diabetes Interventions and Complications (EDIC)

George Washington University0 个研究点目标入组 1,441 人开始时间: 1994年4月1日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

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