NCT01291030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 7, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

4.9 years

First QC Date

February 4, 2011

Last Update Submit

January 16, 2017

Conditions

Glucose MetabolismRenal Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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.

    after 6 months

Secondary Outcomes (1)

  • Evaluation of change in Hemoglobin A1c (HbA1C)

    after 6 months

Study Arms (3)

hypomagnesemic + magnesium supplement

EXPERIMENTAL

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

hypomagnesemic without magnesium supplement

NO INTERVENTION

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.

normomagnesemic without magnesium supplement

NO INTERVENTION

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.

Interventions

magnesium supplementationDIETARY_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.

hypomagnesemic + magnesium supplement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

OLV Aalst

Aalst, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

Study Officials

  • Steven Van Laecke, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2011

First Posted

February 7, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

BE(2)