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The Effect of Magnesium on Early Post-transplantation Glucose Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01889576
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Glucose Metabolism After Transplantation Dietary Supplement: Magnesium Oxide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Magnesium Supplements on Early Post-transplantation Glucose Metabolism: a Randomized Controlled Trial.
Study Start Date : January 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


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).



Primary Outcome Measures :
  1. Fasting glycemia, 3 months after transplantation. [ Time Frame: 3 months after transplantation. ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889576


Locations
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Belgium
Ghent University Hospital
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Astellas Pharma Inc
Investigators
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Principal Investigator: Steven Van Laecke, MD, PhD University Hospital, Ghent
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01889576    
Other Study ID Numbers: IDS BE-02-RG-219
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013
Keywords provided by University Hospital, Ghent:
glucose
Additional relevant MeSH terms:
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Magnesium Oxide
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents