The Effect of Magnesium on Early Post-transplantation Glucose Metabolism

Ghent University Hospital (UZ)

Status: Completed

Conditions: Glucose Metabolism After Transplantation

Treatments: Dietary Supplement: Magnesium Oxide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01889576

IDS BE-02-RG-219

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Supplementation of Magnesium oxide.

Experimental group

Description:

Supplementation of magnesium oxide (450 mg up to 3 times daily maximum), aiming at a serum magnesium concentration of >= 1,9 mg/dL).

Treatment:

Dietary Supplement: Magnesium Oxide

No supplementation or minimal dose.

No Intervention group

Description:

No supplementation (or a minimal dose to keep serum magnesium concentration ≥ 1.2mg/dL depending on the treating physician).