The Effect of Magnesium on Early Post-transplantation Glucose Metabolism

Glucose Metabolism After Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01889576
• Other study ID #: IDS BE-02-RG-219
• Status: Completed
• Phase: N/A
• First received: June 25, 2013
• Last updated: June 27, 2013
• Start date: January 2010
• Est. completion date: September 2012

Study information

• Verified date: June 2013
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Metabolism After Transplantation

Intervention

Dietary Supplement:
• Magnesium Oxide

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Astellas Pharma Inc

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glycemia, 3 months after transplantation.		3 months after transplantation.	No
Secondary	Incidence of diabetes after transplantation the first 3 months after transplantation.		3 months after transplantation.	No
Secondary	Incidence of impaired fasting glucose the first 3 months after transplantation.		3 months after transplantation.	No
Secondary	Insulin sensitivity measured by "Homeostatic Model assessment (HOMA)", 3 months after transplantation.		3 months after transplantation.	No