Magnesium Replacement and Hyperglycemia After Kidney Transplantation
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Magnesium retension at loading test
研究概览
简要总结
The insulin receptor is dependent on magnesium and hypomagnesemia is associated with increased insulin resistance and decreased insulin secretion and action. Recent data suggest that hypomagnesemia may play a role in development of type 2 diabetes. Kidney transplantation patients have low plasma magnesium levels, partly due to treatment with calcineurin inhibitors. However, the role of magnesium in the development of post-transplant diabetes mellitus (PTDM) is unclear.
The present study addresses, whether hypomagnesemia is feasible to reverse by oral administration of magnesium.
The investigators wish to investigate whether oral magnesium supplementation is sufficient to increase magnesium levels in kidney transplant recipients, and if supplementation improves glycemic parameters as measured by an oral glucose tolerance test (OGTT).
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
- Double (Participant, Investigator)
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
- •Kidney transplant recipients more than one year after transplantation
- •Hypomagnesemia (< 0.7 mmol/L)
- •Age ≥ 18 years and able to give written informed consent
排除标准
- •Current treatment with magnesium containing medication or supplements
- •Current medical treatment for diabetes
- •Conditions impairing magnesium absorption from the gastrointestinal tract (e.g. short bowel syndrome, chronic pancreatitis)
- •Subjects with primary non-graft function and subjects with need of dialysis therapy >2 months or graftectomy at any time point after transplantation
研究组 & 干预措施
Mablet
Mablet 360 mg. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total.
干预措施: Mablet 360 mg (Drug)
Placebo
Placebo. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total.
干预措施: Placebo (Drug)
结局指标
主要结局
Magnesium retension at loading test
时间窗: 24 weeks
Difference in magnesium retension at magnesium loading test between before and after oral treatment. Retension defined as percentage of magnesium retained from intravenous magnesium sulphate.
次要结局
- Insulin (mg/kg/min)(2 hours oral glucose tolerance test)
- Plasma glucose (mmol/L)(Baseline (Before magnesium loading tests))
- C-peptide (nmol/L)(2 hours oral glucose tolerance test)
研究者
Trond Jenssen
MD, PhD
Oslo University Hospital