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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Glucose Metabolism Renal Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hypomagnesemic + magnesium supplement

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.

Group Type EXPERIMENTAL

magnesium supplementation

Intervention Type DIETARY_SUPPLEMENT

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.

hypomagnesemic without magnesium supplement

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

normomagnesemic without magnesium supplement

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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magnesium 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No