Clinical trial NCT01889576: The Effect of Magnesium on Early Post-transplantation Glucose Metabolism
Official title: The Effect of Magnesium Supplements on Early Post-transplantation Glucose Metabolism: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism After Transplantation
Keywords: glucose
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2013-06-28
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Fasting glycemia, 3 months after transplantation.
timeFrame: 3 months after transplantation.
Secondary outcomes:
measure: Incidence of diabetes after transplantation the first 3 months after transplantation.
timeFrame: 3 months after transplantation.
measure: Incidence of impaired fasting glucose the first 3 months after transplantation.
timeFrame: 3 months after transplantation.
measure: Insulin sensitivity measured by "Homeostatic Model assessment (HOMA)", 3 months after transplantation.
timeFrame: 3 months after transplantation.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Steven Van Laecke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Laecke S, Nagler EV, Taes Y, Van Biesen W, Peeters P, Vanholder R. The effect of magnesium supplements on early post-transplantation glucose metabolism: a randomized controlled trial. Transpl Int. 2014 Sep;27(9):895-902. doi: 10.1111/tri.12287. Epub 2014 Mar 24.