Studies of Early Diabetic Glomerulopathy-the Relation Between Histopathology, Kidney Function and Metabolic Control. Natural History and Effect of ARB
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Basement membrane thickness
研究概览
简要总结
The type 1 diabetes patients who were still normoalbuminuric and normotensive, after 17 years duration and a second research kidney biopsy, could enter the double blind treatment study of Atacand or Placebo.
The treatment study continues for five years treatment and ends with a third kidney biopsy.
The study hypothesis is that the effect of ARB during 5 years on the histopathology are more pronounced than the effect on histopathology of placebo.
详细描述
46 patients performed a first kidney biopsy between 1992-1994. After 6 years 29 accepted to perform a second biopsy. During the follow-up 10 patients developed complications i.e. hypertension or microalbuminuria. 7 of the patients got treatment during follow up and 3 started the treatment after the second biopsy. 19 patients with two kidney biopsies were still normoalbuminuric and normotensive. 13 of them entered the double-blind treatment study of Atacand or Placebo. 6 denied to participate in the treatment study.
The treatment study will continue for 5 years and will end with a third kidney biopsy. Also the rest of the patients that have done 2 kidney biopsies will be asked to perform a third biopsy.
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
- Double
入排标准
- 年龄范围
- 17 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes type 1 patient
- •Normotensive
- •Normoalbuminuric
- •Signed informed consent
- •Female and male
- •Over 17 years of age
- •Diabetes duration over 10 years
排除标准
- •Hypertension
- •Microalbuminuria
- •Pregnancy
- •Lactation
- •Reduced kidney function
- •Artery stenosis
- •Kidney transplantation
- •Allergy to the medication in the study
- •Reduced liver function
- •Alcohol or drug abuse
- •Participation in another drug or clinical test during last 30 days
- •Severe diseases i.e. malignancy
- •Previously enrolment of the present study
结局指标
主要结局
Basement membrane thickness
Mesangial expansion
次要结局
- Hypertension
- Microalbuminuria
- Kidney Function
- 24 hour ambulatory blood pressure