Magnesium Replacement and Hyperglycemia After Kidney Transplantation

September 27, 2021 updated by: Trond Jenssen, Oslo University Hospital

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Trond Jenssen, Prof, PhD

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mablet
Mablet 360 mg. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total.
Drug: Mablet 360 mg
Slow-released magnesium hydroxide
PLACEBO_COMPARATOR: Placebo
Placebo. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total.
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnesium retension at loading test
Time Frame: 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.
24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 25, 2020

Primary Completion (ANTICIPATED)

August 31, 2022

Study Completion (ANTICIPATED)

August 31, 2022

Study Registration Dates

First Submitted

May 3, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (ACTUAL)

May 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/842

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Transplantation

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe