The Effect of Magnesium on Early Post-transplantation Glucose Metabolism

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01889576

Enrollment

Registered

2013-06-28

Start date

2010-01-31

Completion date

2012-09-30

Last updated

2013-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Metabolism After Transplantation

Keywords

glucose

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.

Interventions

DIETARY_SUPPLEMENTMagnesium Oxide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Fasting glycemia, 3 months after transplantation.	3 months after transplantation.

Secondary

Measure	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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026