The Impact of Magnesium Supplementation on Insulin Resistance and Secretion in Renal Transplant Recipients

Ghent University Hospital (UZ)

Status: Completed

Conditions: Renal Transplantation; Glucose Metabolism

Treatments: Dietary Supplement: magnesium supplementation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01291030

2010/416

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 3 patient groups

hypomagnesemic + magnesium supplement

Experimental group

Description:

The patient group of hypomagnesesemic renal transplant recipients randomized to magnesium supplementation (number = 30). The assessments are a baseline fasting assessment of insulin resistance and an Oral Glucose Tolerance Test with derived indices of insulin secretion,which are repeated after 6 months.

Treatment:

Dietary Supplement: magnesium supplementation

hypomagnesemic without magnesium supplement

No Intervention group

Description:

The patient group of hypomagnesesemic renal transplantation recipients, randomized to no magnesium supplementation (number = 30). During 6 months, no magnesium supplementation is started, provided that the serum magnesium level remains \> 1,2 milligram/deciliter. In case of cramps, intermittent supplementation is allowed, but will be recorded. The assessments are a baseline fasting assessment of insulin resistance and an Oral Glucose Tolerance Test with derived indices of insulin secretion,which are repeated after 6 months.

normomagnesemic without magnesium supplement

No Intervention group

Description:

In the control group of normomagnesemic renal transplantation recipients (number = 10), only a baseline assessment will be performed. The assessments are a baseline fasting assessment of insulin resistance and an Oral Glucose Tolerance Test with derived indices of insulin secretion.