HypomagnesemiaPhase 1/2NCT04382157
Magnesium Replacement and Hyperglycemia After Kidney Transplantation
A Phase 1/2 study testing Mablet 360 mg in people with Hypomagnesemia and Kidney Transplantation, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypomagnesemia, Kidney Transplantation
- What is being tested?
- Mablet 360 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 25 Feb 2020to 31 Aug 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney transplant recipients more than one year after transplantation
- Hypomagnesemia (< 0.7 mmol/L)
- Age ≥ 18 years and able to give written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Trond Jenssen, Prof, PhD contact
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo
Rasmus Carlsen, MD, 004723073544, r.k.carlsen@studmed.uio.no
About this study
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
- Being tested
- Mablet 360 mg, Placebo
- Keywords
- Oral glucose tolerance test, Magnesium hydroxide, hyperglycemia
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mablet 360 mgDrug
Slow-released magnesium hydroxide
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Mablet | Experimental | Mablet 360 mg. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (3)
Plasma glucose (mmol/L)
Change of fasting plasma glucose (mmol/L) between start and the end of supplementation.
Measured: Baseline (Before magnesium loading tests)
Insulin (mg/kg/min)
Change of insulin (mg/kg/min) in OGTT (after 2 hours) between start and the end of supplementation.
Measured: 2 hours oral glucose tolerance test
C-peptide (nmol/L)
Change of C-peptide (nmol/L) in OGTT (after 2 hours) between start and the end of supplementation.
Measured: 2 hours oral glucose tolerance test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start25 Feb 2020
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypomagnesemiaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trond Jenssen, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382157
- Sponsor's protocol ID
- 2019/842
- Status last verified
- Sep 2021
- First submitted
- 3 May 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Replacement and Hyperglycemia After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT04382157
- Acronym / sponsor ID
- 2019/842
- Conditions
- Hypomagnesemia, Kidney Transplantation
- Keywords
- Oral glucose tolerance test, Magnesium hydroxide, hyperglycemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mablet | Experimental | Drug: Mablet 360 mgMablet 360 mg. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Kidney transplant recipients more than one year after transplantation
- Hypomagnesemia (< 0.7 mmol/L)
- Age ≥ 18 years and able to give written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mablet 360 mgSlow-released magnesium hydroxide | Drug | Mablet |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Magnesium retension at loading test
Time frame: 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.
3 secondary outcomes
Plasma glucose (mmol/L)
Time frame: Baseline (Before magnesium loading tests)
Insulin (mg/kg/min)
Time frame: 2 hours oral glucose tolerance test
C-peptide (nmol/L)
Time frame: 2 hours oral glucose tolerance test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Hypomagnesemia
Active, not recruiting
Dietary Magnesium in Preventing Low Blood Magnesium Levels in Patients With Ovarian Cancer Receiving Carboplatin Chemotherapy
Ovarian Carcinoma
Not yet recruiting
Magnesium Supplementation as a Nutritional Intervention in Sarcopenia
Sarcopenia
RecruitingObservational study
The Study of Urinary Biomarkers in Patients With Hypomagnesemia
Hypomagnesemia
RecruitingPhase 4
Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards
Hypomagnesemia
Not yet recruitingPhase 2
MLD10 for the Treatment of Hypomagnesemic Patients With Type 2 Diabetes Mellitus
Hypomagnesemia in Type 2 Diabetic Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trond Jenssen, Prof, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mablet 360 mg in people with Hypomagnesemia and Kidney Transplantation, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rasmus K Carlsen, MD (004723073544, r.k.carlsen@studmed.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnesium retension at loading test (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.