Magnesium Replacement and Hyperglycemia After Kidney Transplantation

NCT ID: NCT04382157

Last Updated: 2021-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-25

Study Completion Date

2022-08-31

Brief Summary

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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

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Conditions

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Hypomagnesemia Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mablet

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

Group Type EXPERIMENTAL

Mablet 360 mg

Intervention Type DRUG

Slow-released magnesium hydroxide

Placebo

Placebo. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Mablet 360 mg

Slow-released magnesium hydroxide

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Trond Jenssen

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Rasmus K Carlsen, MD

Role: CONTACT

004723073544

Trond Jenssen, Prof, PhD

Role: CONTACT

Facility Contacts

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Rasmus Carlsen, MD

Role: primary

004723073544

Other Identifiers

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2019/842

Identifier Type: -

Identifier Source: org_study_id

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