Magnesium Replacement and Hyperglycemia After Kidney Transplantation
Primary Purpose
Hypomagnesemia, Kidney Transplantation
Status
Unknown status
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Mablet 360 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypomagnesemia focused on measuring Oral glucose tolerance test, Magnesium hydroxide, hyperglycemia
Eligibility Criteria
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
Sites / Locations
- Oslo University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mablet
Placebo
Arm Description
Mablet 360 mg. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total.
Placebo. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total.
Outcomes
Primary Outcome Measures
Magnesium retension at loading test
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
Plasma glucose (mmol/L)
Change of fasting plasma glucose (mmol/L) between start and the end of supplementation.
Insulin (mg/kg/min)
Change of insulin (mg/kg/min) in OGTT (after 2 hours) between start and the end of supplementation.
C-peptide (nmol/L)
Change of C-peptide (nmol/L) in OGTT (after 2 hours) between start and the end of supplementation.
Full Information
NCT ID
NCT04382157
First Posted
May 3, 2020
Last Updated
September 27, 2021
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04382157
Brief Title
Magnesium Replacement and Hyperglycemia After Kidney Transplantation
Official Title
Magnesium Replacement and Hyperglycemia After Kidney Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypomagnesemia, Kidney Transplantation
Keywords
Oral glucose tolerance test, Magnesium hydroxide, hyperglycemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mablet
Arm Type
Experimental
Arm Description
Mablet 360 mg. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total.
Intervention Type
Drug
Intervention Name(s)
Mablet 360 mg
Intervention Description
Slow-released magnesium hydroxide
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Magnesium retension at loading test
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Plasma glucose (mmol/L)
Description
Change of fasting plasma glucose (mmol/L) between start and the end of supplementation.
Time Frame
Baseline (Before magnesium loading tests)
Title
Insulin (mg/kg/min)
Description
Change of insulin (mg/kg/min) in OGTT (after 2 hours) between start and the end of supplementation.
Time Frame
2 hours oral glucose tolerance test
Title
C-peptide (nmol/L)
Description
Change of C-peptide (nmol/L) in OGTT (after 2 hours) between start and the end of supplementation.
Time Frame
2 hours oral glucose tolerance test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rasmus K Carlsen, MD
Phone
004723073544
Email
r.k.carlsen@studmed.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Trond Jenssen, Prof, PhD
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rasmus Carlsen, MD
Phone
004723073544
Email
r.k.carlsen@studmed.uio.no
12. IPD Sharing Statement
Plan to Share IPD
No
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Magnesium Replacement and Hyperglycemia After Kidney Transplantation
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