NCT00678522已完成4 期
The Acute Effect of Atorvastatin on Renal Sodium Excretion, Glomerular Filtration Rate, Tubular Function and Vasoactive Hormones in Patients With Non-Insulin Dependent Type II Diabetes.
Regional Hospital Holstebro4 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2007年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- GFR, clearance of sodium and lithium, fractional excretion of sodium and lithium, U-AQP-2, total sodium excretion, albumin excretion rate and free water clearance.
研究概览
简要总结
We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium excretion, glomerular filtration rate, tubular function and vasoactive hormones in patients with type II diabetes, not in treatment with insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 40-70 yrs
- •estimated GFR between 30 and 90 ml/min
- •Fertile women had to use oral contraceptives or IUD
- •HbA1c< 10%
- •Urine-albumin<1,5 g/l
排除标准
- •Treatment with insulin
- •Cerobrovascular insult or other disease of the brain
- •Insufficiency of the heart or lungs
- •Liverdisease with ALAT > 200 U/L
- •hemoglobin < 7,0 mmol/l
- •Alcohol abuse
- •Medical treatment with psycopharmaca or/and analgetics
- •Pregnancy and breast feeding, 10 blood donation one month before the study.
结局指标
主要结局
GFR, clearance of sodium and lithium, fractional excretion of sodium and lithium, U-AQP-2, total sodium excretion, albumin excretion rate and free water clearance.
时间窗: 6 months
次要结局
- AVP, Ang-II, Aldo, ANP, BNP, PRC, BP, HR.(6 months)
研究者
研究点 (4)
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