The Effect of Magnesium on Early Post-transplantation Glucose Metabolism

NCT01889576 | Completed

• 1 other identifier: IDS BE-02-RG-219
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Glucose Metabolism After Transplantation

Keywords

glucose

Outcome Measures

Primary Outcomes (1)

• Fasting glycemia, 3 months after transplantation.

  3 months after transplantation.

Secondary Outcomes (3)

• Incidence of diabetes after transplantation the first 3 months after transplantation.

  3 months after transplantation.

• Incidence of impaired fasting glucose the first 3 months after transplantation.

  3 months after transplantation.

• Insulin sensitivity measured by "Homeostatic Model assessment (HOMA)", 3 months after transplantation.

  3 months after transplantation.

Study Arms (2)

Supplementation of Magnesium oxide.

EXPERIMENTAL

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 supplementation or minimal dose.

NO INTERVENTION

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

Interventions

Magnesium Oxide DIETARY_SUPPLEMENT

Supplementation of Magnesium oxide.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 24909487 DERIVED

MeSH Terms

Interventions

Magnesium Oxide

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Steven Van Laecke, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: June 28, 2013
• Study Start: January 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2012
• Last Updated: June 28, 2013

Record last verified: 2013-06

Locations

BE (1)