The Effect of Magnesium Supplements on Early Post-transplantation Glucose Metabolism: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Fasting glycemia, 3 months after transplantation.
研究概览
简要总结
Hypomagnesemia is common early after transplantation, especially in association with calcineurin inhibitors and predicts diabetes after transplantation. Magnesium improves glycemic control and insulin sensitivity in diabetics and insulin resistant subjects without diabetes but this was never evaluated in transplant recipients.
The aim of the study is to assess whether magnesium improves glycemic control and insulin sensitivity early after transplantation.
The study is an open label study in which adult hypomagnesemic renal transplant recipients are randomized the first 2 weeks after kidney transplantation to magnesium oxide or no supplementation.
The hypothesis is that magnesium supplementation in renal transplant recipients exerts a beneficial effect on glycemia and the development of diabetes after transplantation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal transplantation recipients
- •> 18 years of age
- •Less than 2 weeks post-transplantation
- •Hypomagnesemia < 1,7 milligram/deciliter on 2 consecutive blood samples (laboratory reference interval 1,7 - 2,55 milligram/deciliter).
排除标准
- •Pre-existing diabetes mellitus defined as the intake of anti-diabetic drugs at the time of inclusion
- •Serum creatinine > 3 milligram/deciliter
- •Active infection (C reactive protein > 3 milligram/deciliter)
- •Severe hypomagnesemia (< 1,2 milligram/deciliter)
- •Hypokalemia (< 3,5 milli-equivalent/liter)
- •Severe hypocalcemia (< 6,5 milligram/deciliter)
结局指标
主要结局
Fasting glycemia, 3 months after transplantation.
时间窗: 3 months after transplantation.
次要结局
- Incidence of impaired fasting glucose the first 3 months after transplantation.(3 months after transplantation.)
- Incidence of diabetes after transplantation the first 3 months after transplantation.(3 months after transplantation.)
- Insulin sensitivity measured by "Homeostatic Model assessment (HOMA)", 3 months after transplantation.(3 months after transplantation.)