Renal and Hormonal Effects of Pioglitazone
Effects of the PPAR-gamma Agonist Pioglitazone on Renal and Hormonal Responses to Salt in Diabetic and Hypertensive Subjects
研究概览
详细说明
Aim: Glitazones are powerful insulin sensitizers prescribed for the treatment of type 2 diabetes. Their use is however associated with fluid retention and an increased risk of congestive heart failure. We previously demonstrated that pioglitazone increases proximal sodium reabsorption in healthy volunteers. This study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects.
Methods: In this double-blind, randomized, placebo-controlled, four-way, cross-over study, we examined the effects of pioglitazone (45mg daily during 6 weeks) or placebo on renal, systemic and hormonal responses to changes in sodium intake in 16 individuals, 8 with type 2 diabetic and 8 with hypertension.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Geneva、瑞士、1211
- Pechère-Bertschi Antoinette
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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:
- Type II Diabetes
- Hypertension
Exclusion Criteria:
- Cardiac or renal diseases
- Anaemia
- Drugs like aspirin, non steroidal anti-inflammatory drugs and hormonal replacement therapy.
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：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Pioglitazone
placebo-controlled, randomized, cross-over study
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placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance
其他名称：
placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance
其他名称：
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安慰剂比较：Metformine
placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance
|
placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Effects of Pioglitazone on Renal Hemodynamics
大体时间：2008
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At the end of each treatment diet phase, renal clearances were performed for the determination of GFR and RBF
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2008
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Effects of Pioglitazone on Sodium and Lithium Clearances
大体时间：2007
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At the end of each treatment and diet phase, 24 urine collections were collected for the determination of sodium and lithium clearances
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2007
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Effects of Pioglitazone on 24h Blood Pressure Control
大体时间：march 2009
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24 hour blood pressure measurements were performed after each treatment/diet phase
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march 2009
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Effects of Pioglitazone on Salt Sensitivity
大体时间：2009
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2009
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合作者和调查者
调查人员
- 研究主任：Antoinette Pechere-Bertschi, MD、University Hospital, Geneva
出版物和有用的链接
一般刊物
- Zanchi A, Pechere-Bertschi A, Burnier M, Bonny O. Effects of pioglitazone on renal calcium excretion. J Clin Endocrinol Metab. 2011 Sep;96(9):E1482-5. doi: 10.1210/jc.2011-0373. Epub 2011 Jul 13.
- Zanchi A, Maillard M, Jornayvaz FR, Vinciguerra M, Deleaval P, Nussberger J, Burnier M, Pechere-Bertschi A. Effects of the peroxisome proliferator-activated receptor (PPAR)-gamma agonist pioglitazone on renal and hormonal responses to salt in diabetic and hypertensive individuals. Diabetologia. 2010 Aug;53(8):1568-75. doi: 10.1007/s00125-010-1756-2. Epub 2010 Apr 23.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
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
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