Magnesium Replacement and Hyperglycemia After Kidney Transplantation
NCT ID: NCT04382157
Last Updated: 2021-09-28
Study Results
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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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2020-02-25
2022-08-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
Mablet 360 mg
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.
Placebo
Placebo
Interventions
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Mablet 360 mg
Slow-released magnesium hydroxide
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Hypomagnesemia (\< 0.7 mmol/L)
* Age ≥ 18 years and able to give written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Trond Jenssen
MD, PhD
Locations
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Oslo University Hospital
Oslo, , Norway
Countries
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Central Contacts
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Trond Jenssen, Prof, PhD
Role: CONTACT
Facility Contacts
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Other Identifiers
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2019/842
Identifier Type: -
Identifier Source: org_study_id
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