NCT00422955已完成3 期
A 16-week, Randomised, Double-blind, Placebo-controlled, Single-centre Study to Investigate Fluid Retention in Insulin-treated Subjects With Type 2 Diabetes Mellitus and Varying Degrees of Autonomic Neuropathy When Administered Rosiglitazone 4mg Twice Daily
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in transcapillary escape rate of L125 albumin following 16 weeks treatment
研究概览
简要总结
Fluid management study in patients with type 2 diabetes and autonomic neuropathy.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subjects with an HbA1c level > 12%
- •Subjects taking oral hypoglycaemic agents other than metformin
- •Subjects on insulin dosage > 200 units/day
研究组 & 干预措施
Arm 1
Experimental
干预措施: rosiglitazone (Drug)
结局指标
主要结局
Change in transcapillary escape rate of L125 albumin following 16 weeks treatment
次要结局
- Change in plasma volume, pedal oedema, extracellular fluid volume following 16 weeks treatment.
研究者
研究点 (1)
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