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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplementation of Magnesium oxide. | Experimental | Supplementation of magnesium oxide (450 mg up to 3 times daily maximum), aiming at a serum magnesium concentration of >= 1,9 mg/dL). |
|
| No supplementation or minimal dose. | No Intervention | No supplementation (or a minimal dose to keep serum magnesium concentration ≥ 1.2mg/dL depending on the treating physician). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Oxide | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting glycemia, 3 months after transplantation. | 3 months after transplantation. |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Van Laecke, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24909487 | Derived | 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. |
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| ID | Term |
|---|---|
| D008277 | Magnesium Oxide |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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| Insulin sensitivity measured by "Homeostatic Model assessment (HOMA)", 3 months after transplantation. | 3 months after transplantation. |