Magnesium Replacement and Hyperglycemia After Kidney Transplantation

Study Overview
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Brief Summary
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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).

Official Title
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Magnesium Replacement and Hyperglycemia After Kidney Transplantation

Conditions
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Hypomagnesemia, Kidney Transplantation

Intervention / Treatment
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* Drug: Mablet 360 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Kidney transplant recipients more than one year after transplantation Hypomagnesemia (< 0.7 mmol/L) Age ≥ 18 years and able to give written informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mablet<br>Mablet 360 mg. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total. | Drug: Mablet 360 mg<br>* Slow-released magnesium hydroxide<br>|
| Placebo Comparator: Placebo<br>Placebo. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total. | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnesium retension at loading test | 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. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose (mmol/L) | Change of fasting plasma glucose (mmol/L) between start and the end of supplementation. | Baseline (Before magnesium loading tests) | 
| Insulin (mg/kg/min) | Change of insulin (mg/kg/min) in OGTT (after 2 hours) between start and the end of supplementation. | 2 hours oral glucose tolerance test | 
| C-peptide (nmol/L) | Change of C-peptide (nmol/L) in OGTT (after 2 hours) between start and the end of supplementation. | 2 hours oral glucose tolerance test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral glucose tolerance test, Magnesium hydroxide, hyperglycemia