NL-OMON30227尚未招募2 期
The effect of rosiglitazone on ischemia-reperfusion-injury using annexin A5 scintigraphy. A double blind placebo- controlled cross-over study in subjects with the metabolic syndrome - Rosiglitazone and ischemia-reperfusion-injury in humans
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1). At least 3 features of the metabolic syndrome (AHA/NHLBI) (10)
- •2). Willing and able to provide a signed and dated written informed consent.
- •3). Male and postmenopausal female subjects aged between 20 and 70 years
排除标准
- •1). Fasting glucose > 7,0 mmol/L or the use of hypoglycaemic agents. If fasting plasma glucose is between 6.1 and 7,0 mmol/L,an oral 75 g glucose test will be performed to exclude diabetes mellitus.
- •2). Exposure to a PPAR-g agonist during the last 4 months or a documented significant hypersensitivity to a PPAR-g agonist.
- •3). Participant in another study.
- •4). Angina or heart failure (NYHA I-IV).
- •5). Clinically significant liver disease (3 times the upper normal limit of ALAT, ASAT, AF, γGT or LDH)
- •6). Clinically significant anaemia (male Hb < 6,9 mmol/L, female < 6,25 mmol/L)
- •7). Creatinin clearance < 40 mL/min
- •8). Alcohol or drug abuse.
- •9). Any physical inability to perform the exercise protocol.
- •10). Administration of any radiotracer for research purposes during the previous 5 years.
研究者
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