The Effect of Magnesium on Early Post-transplantation Glucose Metabolism

Not Applicable

Completed

• Conditions: Glucose Metabolism After Transplantation
• Interventions: Dietary Supplement: Magnesium Oxide

• Registration Number: NCT01889576
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2012-06
• Study Completion: 2012-09
• Status Verified: 2013-06
• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-06-27
• Last Update Submitted: 2013-06-27
• Study First Posted: 2013-06-28
• Last Update Posted: 2013-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Fasting glycemia, 3 months after transplantation.	3 months after transplantation.

Secondary Outcome Measures

Name	Time	Method
Incidence of impaired fasting glucose the first 3 months after transplantation.	3 months after transplantation.
Incidence of diabetes after transplantation 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.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium