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The Effect of Magnesium on Early Post-transplantation Glucose Metabolism

NCT ID: NCT01889576

Last Updated: 2013-06-28

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Glucose Metabolism After Transplantation

Keywords

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glucose

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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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).

Group Type EXPERIMENTAL

Magnesium Oxide

Intervention Type DIETARY_SUPPLEMENT

No supplementation or minimal dose.

No supplementation (or a minimal dose to keep serum magnesium concentration ≥ 1.2mg/dL depending on the treating physician).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Magnesium Oxide

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Van Laecke, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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Ghent University Hospital

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 24909487 (View on PubMed)

Other Identifiers

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IDS BE-02-RG-219

Identifier Type: -

Identifier Source: org_study_id