Effects of the PPAR-gamma Agonist Pioglitazone on Renal and Hormonal Responses to Salt in Diabetic and Hypertensive Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Effects of Pioglitazone on Sodium and Lithium Clearances
研究概览
简要总结
This study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type II Diabetes
- •Hypertension
排除标准
- •Cardiac or renal diseases
- •Drugs like aspirin, non steroidal anti-inflammatory drugs and hormonal replacement therapy.
研究组 & 干预措施
Pioglitazone
placebo-controlled, randomized, cross-over study
干预措施: Metformin (Drug)
Pioglitazone
placebo-controlled, randomized, cross-over study
干预措施: Pioglitazone (Drug)
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
干预措施: Metformin (Drug)
结局指标
主要结局
Effects of Pioglitazone on Sodium and Lithium Clearances
时间窗: 2007
At the end of each treatment and diet phase, 24 urine collections were collected for the determination of sodium and lithium clearances
Effects of Pioglitazone on 24h Blood Pressure Control
时间窗: march 2009
24 hour blood pressure measurements were performed after each treatment/diet phase
Effects of Pioglitazone on Renal Hemodynamics
时间窗: 2008
At the end of each treatment diet phase, renal clearances were performed for the determination of GFR and RBF
次要结局
- Effects of Pioglitazone on Salt Sensitivity(2009)