The Effect of Magnesium on Early Post-transplantation Glucose Metabolism
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|ClinicalTrials.gov Identifier: NCT01889576|
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Glucose Metabolism After Transplantation||Dietary Supplement: Magnesium Oxide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Magnesium Supplements on Early Post-transplantation Glucose Metabolism: a Randomized Controlled Trial.|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||September 2012|
Experimental: Supplementation of 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).
Dietary Supplement: Magnesium Oxide
No Intervention: No supplementation or minimal dose.
No supplementation (or a minimal dose to keep serum magnesium concentration ≥ 1.2mg/dL depending on the treating physician).
- Fasting glycemia, 3 months after transplantation. [ Time Frame: 3 months after transplantation. ]
- Incidence of diabetes after transplantation the first 3 months after transplantation. [ Time Frame: 3 months after transplantation. ]
- Incidence of impaired fasting glucose the first 3 months after transplantation. [ Time Frame: 3 months after transplantation. ]
- Insulin sensitivity measured by "Homeostatic Model assessment (HOMA)", 3 months after transplantation. [ Time Frame: 3 months after transplantation. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889576
|Ghent University Hospital|
|Ghent, Belgium, 9000|
|Principal Investigator:||Steven Van Laecke, MD, PhD||University Hospital, Ghent|