The Impact of Magnesium Supplementation on Insulin Resistance and Secretion in Renal Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Evaluation of change in insulin resistance/secretion
研究概览
简要总结
Hypomagnesemia is common in renal transplant recipients and is mainly because of enhanced renal magnesium wasting, caused by immunosuppressive drugs (calcineurin inhibitors). Glucose metabolism disorders, including insulin resistance and decreased insulin secretion, are also prevalent post-transplantation and often precede the development of diabetes. As magnesium supplementation has been demonstrated to increase insulin sensitivity in both diabetic and non-diabetic patients, its potential therapeutic supplementation (post-transplantation) deserves further examination. The hypothesis is that magnesium supplementation in renal transplant recipients exerts a beneficial effect on insulin resistance and/or secretion.
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
- •more than 4 months post-transplantation
- •Hypomagnesemia < 1,8 milligram/deciliter on 2 consecutive blood samples (laboratory reference interval 1,7 - 2,55 milligram/deciliter) at least 1 month apart.
排除标准
- •Pre-existing diabetes mellitus defined as the intake of anti-diabetic drugs at the time of inclusion
- •Biopsy that proves acute rejection and consecutive treatment with corticosteroid boluses less than 2 months before 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)
- •Intake of digoxin
- •Intake of magnesium supplementation up to 2 weeks before randomization.
研究组 & 干预措施
hypomagnesemic + magnesium supplement
The patient group of hypomagnesesemic renal transplant recipients randomized to magnesium supplementation (number = 30). The assessments are a baseline fasting assessment of insulin resistance and an Oral Glucose Tolerance Test with derived indices of insulin secretion,which are repeated after 6 months.
干预措施: magnesium supplementation (Dietary Supplement)
hypomagnesemic without magnesium supplement
The patient group of hypomagnesesemic renal transplantation recipients, randomized to no magnesium supplementation (number = 30). During 6 months, no magnesium supplementation is started, provided that the serum magnesium level remains > 1,2 milligram/deciliter. In case of cramps, intermittent supplementation is allowed, but will be recorded. The assessments are a baseline fasting assessment of insulin resistance and an Oral Glucose Tolerance Test with derived indices of insulin secretion,which are repeated after 6 months.
normomagnesemic without magnesium supplement
In the control group of normomagnesemic renal transplantation recipients (number = 10), only a baseline assessment will be performed. The assessments are a baseline fasting assessment of insulin resistance and an Oral Glucose Tolerance Test with derived indices of insulin secretion.
结局指标
主要结局
Evaluation of change in insulin resistance/secretion
时间窗: after 6 months
The primary outcome of the study is the evaluation of change in insulin resistance and insulin secretion after 6 months of supplementation (versus no supplementation). Insulin resistance is measured by 'Homeostatic Model Assessment' (HOMA) - modeling and the McAuley Index. Insulin secretion is assessed by 'Oral Glucose Tolerance test' (OGTT)- derived indices.
次要结局
- Evaluation of change in Hemoglobin A1c (HbA1C)(after 6 months)