EUCTR2007-004368-34-IE进行中(未招募)不适用
The effects of statin therapy on the osteoprotegerin-RANKL system, correlation with vascular disease and bone metabolism in patients with Type 2 diabetes.
Department of Academic Endocrinology, Beaumont Hospital0 个研究点目标入组 40 人开始时间: 2008年6月4日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age > 40 years
- •Type 2 diabetes
- •HbA1c <7.5%
- •No change in diabetic treatment in last 3 months
- •Stain naïve or currently on no more than 10mg atorvastatin, 40mg pravastatin, or 20mg simvastatin.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Age < 40 years
- •Intolerance to statin therapy
- •Significant hepatic disease precluding statin therapy
- •Current use of > 10mg atorvastatin, 40mg pravastatin, or 20mg simvastatin
- •Type 1 diabetes mellitus
- •Women of child bearing potential
- •Pregnant women
- •Renal dysfunction, defined as a creatinine greater than 150µmol/l
- •History of or current malignancy
- •Treatment with agents known to interfere with OPG/RANKL system such as bisphosphonates, vitamin D, strontium
- •Recent (3 months) change in diabetes treatment
- •Recent vertebral or non-vertebral fracture in the last 6 months
- •Recent (within last 6 months) cardiovascular or cerebrovascular event
- •Recent (within last 6 months) coronary angioplasty
- •Children/Minors (<18 years of age)
- •Unable to read or give informed consent
研究者
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