The Impact of Magnesium Supplementation on Insulin Resistance and Secretion in Renal Transplant Recipients

Renal Transplantation Clinical Trial

Official title:

The Impact of Magnesium Supplementation on Insulin Resistance and Secretion in Renal Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291030
• Other study ID #: 2010/416
• Status: Completed
• Phase: N/A
• First received: February 4, 2011
• Last updated: January 16, 2017
• Start date: January 2011
• Est. completion date: December 2015

Study information

• Verified date: January 2017
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hypomagnesemia is common in renal transplant recipients and is mainly because of enhanced renal magnesium wasting, caused by immunosuppressive drugs (calcineurin inhibitors). Glucose metabolism disorders, including insulin resistance and decreased insulin secretion, are also prevalent post-transplantation and often precede the development of diabetes. As magnesium supplementation has been demonstrated to increase insulin sensitivity in both diabetic and non-diabetic patients, its potential therapeutic supplementation (post-transplantation) deserves further examination. The hypothesis is that magnesium supplementation in renal transplant recipients exerts a beneficial effect on insulin resistance and/or secretion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Renal transplantation recipients

• > 18 years of age

• more than 4 months post-transplantation

• Hypomagnesemia < 1,8 milligram/deciliter on 2 consecutive blood samples (laboratory reference interval 1,7 - 2,55 milligram/deciliter) at least 1 month apart.

Exclusion Criteria:

• Pre-existing diabetes mellitus defined as the intake of anti-diabetic drugs at the time of inclusion

• Biopsy that proves acute rejection and consecutive treatment with corticosteroid boluses less than 2 months before 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)

• Intake of digoxin

• Intake of magnesium supplementation up to 2 weeks before randomization.

Related Conditions & MeSH terms

• Glucose Metabolism
• Insulin Resistance
• Renal Transplantation

Intervention

Dietary Supplement:
• magnesium supplementation
The supplementation starts with 450 mg of magnesium oxide daily, up to a maximum of 3 times 450 mg daily, while aiming at a serum magnesium level of > 1,9 mg/dl.

Locations

Country	Name	City	State
Belgium	OLV Aalst	Aalst
Belgium	University Hospital Ghent	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	Evaluation of change in insulin resistance/secretion	The primary outcome of the study is the evaluation of change in insulin resistance and insulin secretion after 6 months of supplementation (versus no supplementation). Insulin resistance is measured by 'Homeostatic Model Assessment' (HOMA) - modeling and the McAuley Index. Insulin secretion is assessed by 'Oral Glucose Tolerance test' (OGTT)- derived indices.	after 6 months
Secondary	Evaluation of change in Hemoglobin A1c (HbA1C)	The secondary outcome is the evaluation of change in Hemoglobin A1c after 6 months of magnesium supplementation versus no supplementation.	after 6 months

External Links

•   Link