Magnesium Replacement and Hyperglycemia After Kidney Transplantation

Kidney Transplantation Clinical Trial

Official title:

Magnesium Replacement and Hyperglycemia After Kidney Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04382157
• Other study ID #: 2019/842
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 25, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2021
• Source: Oslo University Hospital
• Contact: Rasmus K Carlsen, MD
• Phone: 004723073544
• Email: r.k.carlsen[@]studmed.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia
• Hypomagnesemia
• Kidney Transplantation

Intervention

Drug:
• Mablet 360 mg
Slow-released magnesium hydroxide
• Placebo
Placebo

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 weeks
Secondary	Plasma glucose (mmol/L)	Change of fasting plasma glucose (mmol/L) between start and the end of supplementation.	Baseline (Before magnesium loading tests)
Secondary	Insulin (mg/kg/min)	Change of insulin (mg/kg/min) in OGTT (after 2 hours) between start and the end of supplementation.	2 hours oral glucose tolerance test
Secondary	C-peptide (nmol/L)	Change of C-peptide (nmol/L) in OGTT (after 2 hours) between start and the end of supplementation.	2 hours oral glucose tolerance test