Hypomagnesemia, Kidney Transplantation
Conditions
Keywords
Oral glucose tolerance test, Magnesium hydroxide, hyperglycemia
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).
Interventions
DRUGMablet 360 mg
Slow-released magnesium hydroxide
DRUGPlacebo
Placebo
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucose (mmol/L) | Baseline (Before magnesium loading tests) | Change of fasting plasma glucose (mmol/L) between start and the end of supplementation. |
| 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. |
| 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. |
Countries
Norway
Contacts
Primary ContactRasmus K Carlsen, MD
Backup ContactTrond Jenssen, Prof, PhD
Outcome results
None listed