Diabetes Type 1, Treatment Study Atacand/Placebo After Kidney Biopsy
Studies of Early Diabetic Glomerulopathy-the Relation Between Histopathology, Kidney Function and Metabolic Control. Natural History and Effect of ARB
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.
研究概览
详细说明
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.
研究类型
注册
阶段
- 第四阶段
联系人和位置
学习地点
-
-
-
Stockholm、瑞典、141 86
- Childrens Hospital, Karolinska University Hospital, Huddinge
-
-
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:
- Diabetes type 1 patient
- Normotensive
- Normoalbuminuric
- Signed informed consent
- Female and male
- Over 17 years of age
- Diabetes duration over 10 years
Exclusion Criteria:
- 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
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：双倍的
研究衡量的是什么？
主要结果指标
结果测量 |
|---|
|
Basement membrane thickness
|
|
Mesangial expansion
|
次要结果测量
结果测量 |
|---|
|
微量白蛋白尿
|
|
高血压
|
|
Kidney Function
|
|
24 hour ambulatory blood pressure
|
合作者和调查者
合作者
调查人员
- 首席研究员：Nina ES Perrin, PhD-student、Karolinska University Hospital, Huddinge, B57, Childrens Hospital, 141 86 Stockholm
- 研究主任：Ulla B Berg, Professor、Karolinska University Hospital, B57, Childrens Hospital, 141 86 Stockholm, Sweden
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
研究完成
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
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- SH-AHM-0044-01
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.