The Effect of Magnesium on Early Post-transplantation Glucose Metabolism

June 27, 2013 updated by: University Hospital, Ghent

The Effect of Magnesium Supplements on Early Post-transplantation Glucose Metabolism: a Randomized Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Dietary supplement: Magnesium Oxide
No Intervention: No supplementation or minimal dose.
No supplementation (or a minimal dose to keep serum magnesium concentration ≥ 1.2mg/dL depending on the treating physician).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fasting glycemia, 3 months after transplantation.
Time Frame: 3 months after transplantation.
3 months after transplantation.

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of diabetes after transplantation the first 3 months after transplantation.
Time Frame: 3 months after transplantation.
3 months after transplantation.
Incidence of impaired fasting glucose the first 3 months after transplantation.
Time Frame: 3 months after transplantation.
3 months after transplantation.
Insulin sensitivity measured by "Homeostatic Model assessment (HOMA)", 3 months after transplantation.
Time Frame: 3 months after transplantation.
3 months after transplantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Astellas Pharma Inc

Investigators

  • Principal Investigator: Steven Van Laecke, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

June 27, 2013

First Posted (Estimate)

June 28, 2013

Study Record Updates

Last Update Posted (Estimate)

June 28, 2013

Last Update Submitted That Met QC Criteria

June 27, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDS BE-02-RG-219

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glucose Metabolism After Transplantation

Clinical Trials on Magnesium Oxide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe