Effects of Cyclosporine A on Pancreatic Insulin Secretion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Insulin secretion
研究概览
简要总结
Our primary aim is to investigate if cyclosporine A reduces insulin secretion.
详细描述
Our primary aim is to investigate if cyclosporine A may reduce insulin secretion by 20% or more. In order to get cyclosporine A naïve patients we will perform this investigation in dialysis patients on the waiting list for a renal transplantation. In addition we will investigate if also the peripheral insulin sensitivity and endothelia function is affected by cyclosporine A treatment in these patients. Since these patients will be treated with cyclosporine A we will also measure cyclosporine pharmacokinetics at the time of investigation and repeat this investigation at the time of the first week following transplantation in order to evaluate if a pretransplant cyclosporine dose can be of value in predefining the dose to be used at the time of transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal failure patients on dialysis which is planned to receive a renal transplant
排除标准
- •Age below 18 years or above 75 years
- •Pregnancy
- •Breast feeding mothers
- •Diabetes mellitus /WHO criteria)
- •Dialysis treatment less than 2 months
- •Serious coronary heart disease
- •Unstable angina pectoris
- •Recent acute infarction (less than 3 months)
- •Non-compensated heart failure
- •Simultaneous treatment with glucocorticosteroids (e.g. prednisolone, dexamethasone), diltiazem, verapamil, erythromycin, clarithromycin, telithromycin, rifampicin, fluconazole, itraconazole, ketoconazole, voriconazole, indinavir, nelfinavir, ritonavir, nefazodone, bosentan, carbamazepine, St. John's worth, grapefruit.
结局指标
主要结局
Insulin secretion
次要结局
- Peripheral insulin sensitivity
- Endothelial function
- Pharmacokinetics