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

Not Applicable

Completed

• Conditions: Renal Transplantation; Glucose Metabolism
• Interventions: Dietary Supplement: magnesium supplementation

• Registration Number: NCT01291030
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-04
• Study First Submitted QC: 2011-02-04
• Study First Posted: 2011-02-07
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hypomagnesemic + magnesium supplement	magnesium supplementation	The patient group of hypomagnesesemic renal transplant recipients randomized to magnesium supplementation (number = 30). The assessments are a baseline fasting assessment of insulin resistance and an Oral Glucose Tolerance Test with derived indices of insulin secretion,which are repeated after 6 months.

Primary Outcome Measures

Name	Time	Method
Evaluation of change in insulin resistance/secretion	after 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of change in Hemoglobin A1c (HbA1C)	after 6 months	The secondary outcome is the evaluation of change in Hemoglobin A1c after 6 months of magnesium supplementation versus no supplementation.

Trial Locations

Locations (2)

OLV Aalst; 🇧🇪 Aalst, Belgium

University Hospital Ghent; 🇧🇪 Ghent, Belgium