The Effect of Magnesium Supplements on Early Post-transplantation Glucose Metabolism: a Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Ghent
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Fasting glycemia, 3 months after transplantation.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
No supplementation or minimal dose.
No supplementation (or a minimal dose to keep serum magnesium concentration ≥ 1.2mg/dL depending on the treating physician).
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).
Intervention: Magnesium Oxide (Dietary Supplement)
Outcomes
Primary Outcomes
Fasting glycemia, 3 months after transplantation.
Time Frame: 3 months after transplantation.
Secondary Outcomes
- 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.)