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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glucose Metabolism Renal Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OLV Aalst, Aalst, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnesium Supplementation

Dietary Supplement

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.

Primary outcomes

Evaluation of change in insulin resistance/secretion

Time frame: 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 outcomes

Evaluation of change in Hemoglobin A1c (HbA1C)

Time frame: after 6 months

The secondary outcome is the evaluation of change in Hemoglobin A1c after 6 months of magnesium supplementation versus no supplementation.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

Astellas Pharma Inc

Registry information

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Feb 7, 2011
Registry last updated: Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed