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

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01291030
First received: February 4, 2011
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Glucose Metabolism
Renal Transplantation
Dietary Supplement: magnesium supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Magnesium Supplementation on Insulin Resistance and Secretion in Renal Transplant Recipients

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Evaluation of change in insulin resistance/secretion [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
    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:
  • Evaluation of change in Hemoglobin A1c (HbA1C) [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
    The secondary outcome is the evaluation of change in Hemoglobin A1c after 6 months of magnesium supplementation versus no supplementation.


Estimated Enrollment: 70
Study Start Date: January 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hypomagnesemic + magnesium supplement
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.
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.
No Intervention: hypomagnesemic without magnesium supplement
The patient group of hypomagnesesemic renal transplantation recipients, randomized to no magnesium supplementation (number = 30). During 6 months, no magnesium supplementation is started, provided that the serum magnesium level remains > 1,2 milligram/deciliter. In case of cramps, intermittent supplementation is allowed, but will be recorded. 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.
No Intervention: normomagnesemic without magnesium supplement
In the control group of normomagnesemic renal transplantation recipients (number = 10), only a baseline assessment will be performed. The assessments are a baseline fasting assessment of insulin resistance and an Oral Glucose Tolerance Test with derived indices of insulin secretion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291030

Contacts
Contact: Steven Van Laecke, MD Steven.Vanlaecke@ugent.be

Locations
Belgium
OLV Aalst Recruiting
Aalst, Belgium
Contact: Bruno Van Vlem, M.D.       Bruno.Vanvlem@olvz-aalst.be   
Principal Investigator: Bruno Van Vlem, M.D.         
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Steven Van Laecke, MD       Steven.Vanlaecke@ugent.be   
Principal Investigator: Steven Van Laecke, MD         
Sponsors and Collaborators
University Hospital, Ghent
Astellas Pharma Inc
Investigators
Principal Investigator: Steven Van Laecke, MD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01291030     History of Changes
Other Study ID Numbers: 2010/416
Study First Received: February 4, 2011
Last Updated: January 29, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014