Magnesium Replacement and Hyperglycemia After Kidney Transplantation

Phase 1

• Conditions: Hypomagnesemia; Kidney Transplantation
• Interventions: Drug: Mablet 360 mg; Drug: Placebo

• Registration Number: NCT04382157
• Lead Sponsor: Oslo University Hospital

Brief Summary

The insulin receptor is dependent on magnesium and hypomagnesemia is associated with increased insulin resistance and decreased insulin secretion and action. Recent data suggest that hypomagnesemia may play a role in development of type 2 diabetes. Kidney transplantation patients have low plasma magnesium levels, partly due to treatment with calcineurin inhibitors. However, the role of magnesium in the development of post-transplant diabetes mellitus (PTDM) is unclear.

The present study addresses, whether hypomagnesemia is feasible to reverse by oral administration of magnesium.

The investigators wish to investigate whether oral magnesium supplementation is sufficient to increase magnesium levels in kidney transplant recipients, and if supplementation improves glycemic parameters as measured by an oral glucose tolerance test (OGTT).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-25
• Study First Submitted: 2020-05-03
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-11
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Kidney transplant recipients more than one year after transplantation
• Hypomagnesemia (< 0.7 mmol/L)
• Age ≥ 18 years and able to give written informed consent

Exclusion Criteria

• Current treatment with magnesium containing medication or supplements
• Current medical treatment for diabetes
• Conditions impairing magnesium absorption from the gastrointestinal tract (e.g. short bowel syndrome, chronic pancreatitis)
• Subjects with primary non-graft function and subjects with need of dialysis therapy >2 months or graftectomy at any time point after transplantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mablet	Mablet 360 mg	Mablet 360 mg. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total.
Placebo	Placebo	Placebo. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total.

Primary Outcome Measures

Name	Time	Method
Magnesium retension at loading test	24 weeks	Difference in magnesium retension at magnesium loading test between before and after oral treatment. Retension defined as percentage of magnesium retained from intravenous magnesium sulphate.

Secondary Outcome Measures

Name	Time	Method
Insulin (mg/kg/min)	2 hours oral glucose tolerance test	Change of insulin (mg/kg/min) in OGTT (after 2 hours) between start and the end of supplementation.
Plasma glucose (mmol/L)	Baseline (Before magnesium loading tests)	Change of fasting plasma glucose (mmol/L) between start and the end of supplementation.
C-peptide (nmol/L)	2 hours oral glucose tolerance test	Change of C-peptide (nmol/L) in OGTT (after 2 hours) between start and the end of supplementation.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway