Effect of Dietary Protein Restriction on Prognosis in Patients With Diabetic Nephropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Rate of decline of GFR
研究概览
简要总结
The purpose of the investigators study was to determine the effect of dietary protein restriction on survival and progression to end stage renal disease (ESRD) in diabetic nephropathy.
详细描述
The study was a prospective, randomized, unmasked, controlled trial carried out at the Steno Diabetes Center. With concealed randomization the patients were (in blocks of two according to the level of GFR) assigned to receive either a usual-protein diet or a low-protein diet.
After randomization an iso-caloric low-protein diet of 0.6 g/kg/day was prescribed to patients in the low-protein diet group. The usual-pro tein diet consisted of the patients' pre-study diet.
The planned duration of follow-up was four years, scheduled visits every three-months. All patients gave complete history of medication, underwent examination of weight, urinary albumin-, sodium- and urea excretion, serum albumin, serum urea, hemoglobin, hemoglobin A1c, blood pressure, serum total-cholesterol, high-density lipoprotein (HDL) cholesterol.
GFR, serum triglycerides,calcium and phosphorous, anthropometric measurements, nutritional status and smoking habits were evaluated every six months.
Dietary protein intake was estimated on the basis of three consecutive 24-hour urine samples completed before each visit, using urinary excretion of urea nitrogen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus type 1
- •duration at least 10 years
- •onset before age of 35,
- •presence of diabetic retinopathy
- •albuminuria>=300mg/24 h in at least 2/3 sterile urine samples
- •no clinical or laboratory evidence of other kidney or urinary tract disease
- •GFR above 20mL/min/1.73M2
- •pre-study decline in GFR>= 2 mL/min/year
排除标准
- •pregnancy
- •history of congestive heart failure or myocardial infarction or coronary bypass surgery within the last three months
研究组 & 干预措施
Low protein diet
干预措施: low protein diet (Dietary Supplement)
Normal protein diet
干预措施: normal protein diet (Dietary Supplement)
结局指标
主要结局
Rate of decline of GFR
时间窗: 4 years
rate of decline was measured if the patient had a minimum of one year of follow up and a minimum of 3 GFR measures during the study. All measures of GFR during the study period (including baseline) were used to calculate the rate of decline(the slopes) of GFR. GFR was measured every 6 months during the 4 years of follow up.
Cumulative incidence of ESRD requiring dialysis or transplantation, and death
时间窗: 4 years
Cause of death was obtained from death certificate by an independent observer. Before the development of uremic symptoms, patients were referred to the department of nephrology at the University Hospital of Herlev or Rigshospitalet, when GFR deteriorated below 10 to 20 ML/min/1.73m2, where accepted criteria for initiation of dialysis and transplantation were applied on patients from both diet groups. Patients continued their scheduled visits and treatment in the study until the end of the four-year follow up. This was assesed every 3 months until the end of the 4 year follow up period.
次要结局
未报告次要终点
研究者
Peter Rossing
Chief physician and Director of Research
Steno Diabetes Center Copenhagen