NCT00837655撤回不适用
Study of the Effect of Treatment With Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in insulin sensitivity and/or glucose tolerance from baseline to the end of the study, as obtained by ISIOGTT.
研究概览
简要总结
The purpose of this study is to perform a randomized, controlled clinical trial to investigate if the phosphate binder sevelamer can improve insulin resistance and glucose handling in patients receiving maintenance hemodialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 18-80 years of age with chronic renal failure treated with maintenance HD for >3 months.
排除标准
- •Diabetes mellitus
- •Treatment with sevelamer within 3 months prior to enrollment
- •Acute, clinically significant inflammation within 1 month prior to enrollment
- •Pregnancy or breast-feeding
- •Clinically significant obstipation or bowel obstruction
- •Discontinuation of previous sevelamer treatment because of side effects
- •Expected time in HD < 1 year
- •Unwillingness to undergo the investigations and follow-up required in the the protocol
- •Patients who have received any investigational drug within 1 month prior to enrolment
- •Participation in another study, which may interfere with the present study
研究组 & 干预措施
1
Experimental
Sevelamer intervention
干预措施: Sevelamer (Drug)
2
Active Comparator
Calcium carbonate
干预措施: Calcium carbonate (Drug)
结局指标
主要结局
Change in insulin sensitivity and/or glucose tolerance from baseline to the end of the study, as obtained by ISIOGTT.
时间窗: Week 12
次要结局
- Change from baseline to the end of the trial in surrogate markers of phosphate balance (PTH, s-urea, s-creatinine, ionized Ca, phosphate).(Week 12)
- Change from baseline to end of the study in markers of lipid homeostasis (total cholesterol, LDL, HDL, ApoA, ApoB, TG, free fatty acids)(Week 12)
- Change from baseline to the end of the study in circulating inflammatory cytokines (hsCRP, TNF, fibrinogen, PAI, fetuin)(Week 12)
- Number of adverse events directly attributable to sevelamer or calciumcarbonate treatments.(Weekly until end of study)
研究者
研究点 (2)
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