Effects of Disease Management on Development of End Stage Renal Disease in Type 2 Diabetic Patients With Nephropathy
A Multicentre, Randomised Study to Examine the Effects of Disease Management on Development of End Stage Renal Disease in Type 2 Diabetic Patients With Nephropathy
研究概览
详细说明
Diabetic patients consume over 10% of health care costs in most developed countries. Over 80% of these resources are used to treat diabetic complications and late stage diseases. Over 30% of patients admitted to the medical wards in Hong Kong's public hospitals have diabetes, mainly due to cardiovascular and renal complications. Diabetes is now the leading cause of end stage renal disease (ESRD), accounting for 30-50% of patients on renal replacement therapy (RRT). In Hong Kong, the number of patients receiving RRT have increased by 50% in the last 5 years but the number of patients with ESRD due to diabetes have doubled. Between 10% and 15% of patients attending medical clinics in local public hospitals either receive insulin or anti-diabetic drugs. In both community and hospital settings, between 30% and 50% of diabetic patients have albuminuria, which is by far the most powerful predictor for early mortality, cardiovascular morbidity and renal disease. Local published data show that 3-10% of diabetic patients died or developed clinical endpoints yearly.
There are now overwhelming evidence supporting the beneficial effects of optimal control of cardiovascular risk factors on clinical outcomes in diabetic patients. However, there are few studies to examine the most effective way to translate these scientific evidence collected in closely monitored clinical trial situations into daily clinical practice. Results from this multi-centre, randomized study will provide important information to health care policy makers regarding the cost effectiveness of disease management using a multidisciplinary team to deliver a structured care model in light of the growing diabetes epidemic and the constraints of finite resources and the need for equity.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Hong Kong、中国
- The Chinese University of Hong Kong
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Type 2 diabetic patients with ages between 35 and 75 years (inclusive) and defined according to the 1998 WHO criteria and no history of unprovoked ketosis and not requiring continuous insulin treatment within 1 year of diagnosis
- Plasma creatinine 150-350 mmol/l (inclusive) who had no microscopic haematuria and no ultrasonographic evidence of obstructive uropathy which is amenable to surgical intervention
Exclusion Criteria:
- patients with malignancy or other life-threatening diseases
- ultrasonographic evidence of obstructive uropathy which is amenable to surgical intervention
- non-diabetes related renal disease such as glomerulonephritis proven on renal biopsy reversible kidney disease, to be ruled out by ultrasonographic examination
- patients with clinically unstable psychiatric illnesses
- Patients who have 2 consecutive values of plasma creatinine concentration which differ by more than 20% within 3 months prior to recruitment.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Death and/or ESRD defined as need for dialysis or plasma creatinine 500mmol/l
大体时间:May 2003 - Dec 2007
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May 2003 - Dec 2007
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次要结果测量
结果测量 |
大体时间 |
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Composite cardiovascular endpoints (acute myocardial infarction, revascularisation procedures, heart failure or unstable angina or arrhythmia requiring hospital admissions, lower extremity amputation)
大体时间:May 2003 - Dec 2007
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May 2003 - Dec 2007
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Number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department
大体时间:May 2003 - Dec 2007
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May 2003 - Dec 2007
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合作者和调查者
调查人员
- 首席研究员:Juliana CN Chan, MB ChB, MD、Department of Medicine and Therapeutics, The Chinese University of Hong Kong, The Prince of Wales Hospital, Shatin
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Multidisciplinary team care的临床试验
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Jennifer B. LevinAmerican Heart Association主动,不招人
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University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Splendor-NC招聘中
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University of ManitobaJuvenile Diabetes Research Foundation; Canadian Institutes of Health Research (CIHR)尚未招聘体力活动 | 1 型糖尿病
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The Hospital for Sick ChildrenEhave; Ontario Brain Institute完全的
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Case Western Reserve UniversityNational Institute of Nursing Research (NINR)招聘中
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The Hospital for Sick ChildrenChild-Bright Network; Ehave; The Governors of the University of Alberta招聘中