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临床试验/NCT00715481
NCT00715481已完成不适用

Reduced Estimated Glomerular Filtration Rate (eGFR)and Prediction of Cardiovascular Disease and Renal Outcome in Subjects With Type 2 Diabetes: Italian Multicenter Study

Diabetic Nephropathy Study Group19 个研究点 分布在 1 个国家目标入组 15,628 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15,628
试验地点
19
主要终点
cardiovascular morbidity and mortality

研究概览

简要总结

Reduced glomerular filtration rate (GFR) has been recently shown to be a powerful predictor of cardiovascular morbidity and mortality in the general population, independent of traditional cardiovascular risk factors.

This observational study is aimed at assessing the association of reduced estimated GFR with cardiovascular morbidity and mortality in a large italian population (at least 15,000 subjects) of type 2 diabetic outpatients over a 4-year follow-up.

详细描述

Reduced GFR has been recently shown to be a powerful predictor of cardiovascular morbidity and mortality in the general population, independent of traditional cardiovascular risk factors. Since type 2 diabetic patients show increased cardiovascular morbidity and mortality as compared with the general population, the identification of predictors of cardiovascular disease in these patients is of fundamental importance for clinical purposes. One of these predictors is increased urinary albumin excretion rate, which is associated with an increased risk of cardiovascular disease more than of end-stage renal disease. However, a growing body of evidence indicates that a significant proportion of normoalbuminuric diabetic patients, particularly with type 2 diabetes, may exhibit reduced GFR. It is currently unknown the predictive role of this abnormality toward cardiovascular events and death, independent of albuminuria and other known risk factors, in the diabetic population.

This observational study is aimed at assessing the association of reduced estimated GFR with cardiovascular morbidity and mortality in a large italian population (at least 15,000 subjects) of type 2 diabetic nondialytic outpatients over a 4-year follow-up.

Secondary endpoints are to assess in this population:

  • the prevalence and incidence of reduced GFR, as classified according to the National Kidney Foundation criteria, and its association with traditional cardiovascular risk factors;
  • the prevalence, incidence and cardiovascular predictivity of micro and macroalbuminuria.

Patients will be recruited from electronic records of 20 italian outpatients diabetic clinics.

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
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • type 2 diabetes

排除标准

  • dyalisis or renal transplantation

结局指标

主要结局

cardiovascular morbidity and mortality

时间窗: 4 years

次要结局

  • micro/macroalbuminuria(4 years)
  • eGFR, as classified according to the National Kidney Foundation criteria(4 years)
  • traditional cardiovascular risk factors(4 years)

研究者

发起方
Diabetic Nephropathy Study Group
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe Pugliese

Professor of Endocrinology and Metabolism

Diabetic Nephropathy Study Group

研究点 (19)

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