Magnesium Replacement and Hyperglycemia After Kidney Transplantation

NCT04382157 | Unknown Phase 1 DMC

• 1 other identifier: 2019/842
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypomagnesemia; Kidney Transplantation

Keywords

Oral glucose tolerance test; Magnesium hydroxide; hyperglycemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Plasma glucose (mmol/L)

  Baseline (Before magnesium loading tests)

• Insulin (mg/kg/min)

  2 hours oral glucose tolerance test

• C-peptide (nmol/L)

  2 hours oral glucose tolerance test

Study Arms (2)

Mablet

EXPERIMENTAL

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

Drug: Mablet 360 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Mablet 360 mg DRUG

Slow-released magnesium hydroxide

Mablet

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kidney transplant recipients more than one year after transplantation
• Hypomagnesemia (\< 0.7 mmol/L)
• Age ≥ 18 years and able to give written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Rasmus K Carlsen, MD

CONTACT

004723073544; r.k.carlsen@studmed.uio.no

Trond Jenssen, Prof, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 11, 2020
• Study Start: February 25, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)