The Impact of Magnesium Supplementation on Insulin Resistance and Secretion in Renal Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT01291030|
Recruitment Status : Completed
First Posted : February 7, 2011
Last Update Posted : January 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glucose Metabolism Renal Transplantation||Dietary Supplement: magnesium supplementation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Magnesium Supplementation on Insulin Resistance and Secretion in Renal Transplant Recipients|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291030
|University Hospital Ghent|
|Ghent, Belgium, 9000|
|Principal Investigator:||Steven Van Laecke, MD||University Hospital, Ghent|