The Effect of Magnesium on Early Post-transplantation Glucose Metabolism

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Magnesium Supplements on Early Post-transplantation Glucose Metabolism: a Randomized Controlled Trial.

Conditions
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Glucose Metabolism After Transplantation

Intervention / Treatment
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* Dietary Supplement: Magnesium Oxide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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)

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplementation of Magnesium oxide.<br>Supplementation of magnesium oxide (450 mg up to 3 times daily maximum), aiming at a serum magnesium concentration of >= 1,9 mg/dL). | Dietary Supplement: Magnesium Oxide<br> <br> |
| No Intervention: No supplementation or minimal dose.<br>No supplementation (or a minimal dose to keep serum magnesium concentration ≥ 1.2mg/dL depending on the treating physician). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glycemia, 3 months after transplantation. |  | 3 months after transplantation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of diabetes after transplantation the first 3 months after transplantation. |  | 3 months after transplantation. | 
| Incidence of impaired fasting glucose 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucose