Back to resultsThe Impact of Magnesium Supplementation on Insulin Resistance and Secretion in Renal Transplant Recipients
Primary Purpose
Glucose Metabolism, Renal Transplantation
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
magnesium supplementation
Sponsored by
About this trial
This is an interventional treatment trial for Glucose Metabolism
Eligibility 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.
Sites / Locations
- OLV Aalst
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
hypomagnesemic + magnesium supplement
hypomagnesemic without magnesium supplement
normomagnesemic without magnesium supplement
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01291030
First Posted
February 4, 2011
Last Updated
January 16, 2017
Sponsor
University Hospital, Ghent
Collaborators
Astellas Pharma Inc
1. Study Identification
Unique Protocol Identification Number
NCT01291030
Brief Title
The Impact of Magnesium Supplementation on Insulin Resistance and Secretion in Renal Transplant Recipients
Official Title
The Impact of Magnesium Supplementation on Insulin Resistance and Secretion in Renal Transplant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism, Renal Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hypomagnesemic + magnesium supplement
Arm Type
Experimental
Arm Description
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.
Arm Title
hypomagnesemic without magnesium supplement
Arm Type
No Intervention
Arm Description
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.
Arm Title
normomagnesemic without magnesium supplement
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
magnesium supplementation
Intervention Description
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 Outcome Measure Information:
Title
Evaluation of change in insulin resistance/secretion
Description
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.
Time Frame
after 6 months
Secondary Outcome Measure Information:
Title
Evaluation of change in Hemoglobin A1c (HbA1C)
Description
The secondary outcome is the evaluation of change in Hemoglobin A1c after 6 months of magnesium supplementation versus no supplementation.
Time Frame
after 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Van Laecke, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
OLV Aalst
City
Aalst
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Related Info
Learn more about this trial
The Impact of Magnesium Supplementation on Insulin Resistance and Secretion in Renal Transplant Recipients
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