Glucose Metabolism, Renal Transplantation
Conditions
Brief summary
Hypomagnesemia is common in renal transplant recipients and is mainly because of enhanced renal magnesium wasting, caused by immunosuppressive drugs (calcineurin inhibitors). Glucose metabolism disorders, including insulin resistance and decreased insulin secretion, are also prevalent post-transplantation and often precede the development of diabetes. As magnesium supplementation has been demonstrated to increase insulin sensitivity in both diabetic and non-diabetic patients, its potential therapeutic supplementation (post-transplantation) deserves further examination. The hypothesis is that magnesium supplementation in renal transplant recipients exerts a beneficial effect on insulin resistance and/or secretion.
Interventions
DIETARY_SUPPLEMENTmagnesium supplementation
The supplementation starts with 450 mg of magnesium oxide daily, up to a maximum of 3 times 450 mg daily, while aiming at a serum magnesium level of \> 1,9 mg/dl.
Sponsors
Astellas Pharma Inc
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Renal transplantation recipients * \> 18 years of age * more than 4 months post-transplantation * Hypomagnesemia \< 1,8 milligram/deciliter on 2 consecutive blood samples (laboratory reference interval 1,7 - 2,55 milligram/deciliter) at least 1 month apart.
Exclusion criteria
* Pre-existing diabetes mellitus defined as the intake of anti-diabetic drugs at the time of inclusion * Biopsy that proves acute rejection and consecutive treatment with corticosteroid boluses less than 2 months before 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) * Intake of digoxin * Intake of magnesium supplementation up to 2 weeks before randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of change in insulin resistance/secretion | after 6 months | The primary outcome of the study is the evaluation of change in insulin resistance and insulin secretion after 6 months of supplementation (versus no supplementation). Insulin resistance is measured by 'Homeostatic Model Assessment' (HOMA) - modeling and the McAuley Index. Insulin secretion is assessed by 'Oral Glucose Tolerance test' (OGTT)- derived indices. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of change in Hemoglobin A1c (HbA1C) | after 6 months | The secondary outcome is the evaluation of change in Hemoglobin A1c after 6 months of magnesium supplementation versus no supplementation. |
Countries
Belgium
Outcome results
None listed