NCT00448526终止不适用
Effect of Low Protein Diet in Preventing the Progression of Diabetic Nephropathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 主要终点
- annual change of GFR
研究概览
简要总结
Diabetic nephropathy is the leading cause of chronic kidney disease all the world in spite of progress in new treatment for diabetes and anti hypertensive drugs. Additional treatments are thus needed to arrest the progression of diabetic nephropathy. Although there is insufficient evidence to suggest that a low-protein diet improves renal dysfunction, it is recommended as a mainstay of nutritional management. We here assessed the role of low protein diet in renal function as well as albuminuria in type 2 diabetic patients with nephropathy for a median of 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Urinary protein excretion 1-10 g/day
- •Serum Cr <2.0 mg/dl
- •With diabetic retinopathy > SDR
- •Normal protein intake instruction
- •Patients whose consent is obtained at >20 or age =<65
排除标准
- •Type 1 Diabetes Mellitus
- •Non-diabetic nephropathy
- •Urinary tract infection
- •Congestive heart failure
- •Unstable angina
- •Myocardial infarction
- •Severe hepatopathy
- •Life threatening disease such as malignant tumor
- •Patients on ACE-I and or ARB treatment
- •Patients on instruction of low protein diet
- •BW< 80% of IBW
- •Pregnant, lactating, and probably pregnant patients
- •Patients judged as being inappropriate fir the subjects
结局指标
主要结局
annual change of GFR
annual change of Ccr
annual change of 1/Cr
time to the doubling of sCr
incidence rate of the doubling of sCr
次要结局
- urinary albumin and protein excretion
- % change of urinary albumin and protein excretion from baseline
研究者
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