Glucose Metabolism After TransplantationNCT01889576
The Effect of Magnesium on Early Post-transplantation Glucose Metabolism
A study testing Magnesium Oxide in people with Glucose Metabolism After Transplantation, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Hypomagnesemia is common early after transplantation, especially in association with calcineurin inhibitors and predicts diabetes after transplantation. Magnesium improves glycemic control and insulin sensitivity in diabetics and insulin resistant subjects without diabetes but this was never evaluated in transplant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glucose Metabolism After Transplantation
- What is being tested?
- Magnesium Oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2010to Sep 2012
- Phase
- Interventional
- 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
- Renal transplantation recipients
- > 18 years of age
- Less than 2 weeks post-transplantation
- Hypomagnesemia < 1,7 milligram/deciliter on 2 consecutive blood samples (laboratory reference interval 1,7 - 2,55 milligram/deciliter).
Who cannot join
- Pre-existing diabetes mellitus defined as the intake of anti-diabetic drugs at the time of inclusion
- Serum creatinine > 3 milligram/deciliter
- Active infection (C reactive protein > 3 milligram/deciliter)
- Severe hypomagnesemia (< 1,2 milligram/deciliter)
- Hypokalemia (< 3,5 milli-equivalent/liter)
- Severe hypocalcemia (< 6,5 milligram/deciliter)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Magnesium Supplements on Early Post-transplantation Glucose Metabolism: a Randomized Controlled Trial.
Hypomagnesemia is common early after transplantation, especially in association with calcineurin inhibitors and predicts diabetes after transplantation. Magnesium improves glycemic control and insulin sensitivity in diabetics and insulin resistant subjects without diabetes but this was never evaluated in transplant recipients.
The aim of the study is to assess whether magnesium improves glycemic control and insulin sensitivity early after transplantation.
Read more
The study is an open label study in which adult hypomagnesemic renal transplant recipients are randomized the first 2 weeks after kidney transplantation to magnesium oxide or no supplementation.
The hypothesis is that magnesium supplementation in renal transplant recipients exerts a beneficial effect on glycemia and the development of diabetes after transplantation.
- Conditions
- Glucose Metabolism After Transplantation
- Being tested
- Magnesium Oxide
- Keywords
- glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium OxideDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Supplementation of Magnesium oxide. | Experimental | Supplementation of magnesium oxide (450 mg up to 3 times daily maximum), aiming at a serum magnesium concentration of >= 1,9 mg/dL). Receives: Dietary Supplement: Magnesium Oxide |
| No supplementation or minimal dose. | No intervention | No supplementation (or a minimal dose to keep serum magnesium concentration ≥ 1.2mg/dL depending on the treating physician). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glycemia, 3 months after transplantation.
Measured: 3 months after transplantation.
Secondary outcomes (3)
Incidence of diabetes after transplantation the first 3 months after transplantation.
Measured: 3 months after transplantation.
Incidence of impaired fasting glucose the first 3 months after transplantation.
Measured: 3 months after transplantation.
Insulin sensitivity measured by "Homeostatic Model assessment (HOMA)", 3 months after transplantation.
Measured: 3 months after transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startJan 2010
- Primary completionJun 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glucose Metabolism After TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Steven Van Laecke, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889576
- Sponsor's protocol ID
- IDS BE-02-RG-219
- Status last verified
- Jun 2013
- First submitted
- 25 Jun 2013
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Van Laecke S, Nagler EV, Taes Y, Van Biesen W, Peeters P, Vanholder R. The effect of magnesium supplements on early post-transplantation glucose metabolism: a randomized controlled trial. Transpl Int. 2014 Sep;27(9):895-902. doi: 10.1111/tri.12287. Epub 2014 Mar 24.
PubMed 24909487
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Magnesium Supplements on Early Post-transplantation Glucose Metabolism: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01889576
- Acronym / sponsor ID
- IDS BE-02-RG-219
- Conditions
- Glucose Metabolism After Transplantation
- Keywords
- glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Jan 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 28 Jun 2013 (estimated)
- 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.
Hypomagnesemia is common early after transplantation, especially in association with calcineurin inhibitors and predicts diabetes after transplantation. Magnesium improves glycemic control and insulin sensitivity in diabetics and insulin resistant subjects without diabetes but this was never evaluated in transplant recipients.
The aim of the study is to assess whether magnesium improves glycemic control and insulin sensitivity early after transplantation.
The study is an open label study in which adult hypomagnesemic renal transplant recipients are randomized the first 2 weeks after kidney transplantation to magnesium oxide or no supplementation.
The hypothesis is that magnesium supplementation in renal transplant recipients exerts a beneficial effect on glycemia and the development of diabetes after transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplementation of Magnesium oxide. | Experimental | Dietary Supplement: Magnesium OxideSupplementation of magnesium oxide (450 mg up to 3 times daily maximum), aiming at a serum magnesium concentration of >= 1,9 mg/dL). |
| No supplementation or minimal dose. | No intervention | –No supplementation (or a minimal dose to keep serum magnesium concentration ≥ 1.2mg/dL depending on the treating physician). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Renal transplantation recipients
- > 18 years of age
- Less than 2 weeks post-transplantation
- Hypomagnesemia < 1,7 milligram/deciliter on 2 consecutive blood samples (laboratory reference interval 1,7 - 2,55 milligram/deciliter).
Key exclusion criteria (6 listed)
- Pre-existing diabetes mellitus defined as the intake of anti-diabetic drugs at the time of inclusion
- Serum creatinine > 3 milligram/deciliter
- Active infection (C reactive protein > 3 milligram/deciliter)
- Severe hypomagnesemia (< 1,2 milligram/deciliter)
- Hypokalemia (< 3,5 milli-equivalent/liter)
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 |
|---|---|---|
| Magnesium Oxide | Dietary supplement | Supplementation of Magnesium oxide. |
Primary outcome
Fasting glycemia, 3 months after transplantation.
Time frame: 3 months after transplantation.
3 secondary outcomes
Incidence of diabetes after transplantation the first 3 months after transplantation.
Time frame: 3 months after transplantation.
Incidence of impaired fasting glucose the first 3 months after transplantation.
Time frame: 3 months after transplantation.
Insulin sensitivity measured by "Homeostatic Model assessment (HOMA)", 3 months after transplantation.
Time frame: 3 months after transplantation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
- Derived from this study: PubMed 24909487Van Laecke S, Nagler EV, Taes Y, Van Biesen W, Peeters P, Vanholder R. The effect of magnesium supplements on early post-transplantation glucose metabolism: a randomized controlled trial. Transpl Int. 2014 Sep;27(9):895-902. doi: 10.1111/tri.12287. Epub 2014 Mar 24.
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.
Steven Van Laecke, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Oxide in people with Glucose Metabolism After Transplantation, run by University Hospital, Ghent at 1 site in Belgium.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 28 Jun 2013. 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 Belgium. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting glycemia, 3 months after transplantation. (time frame: 3 months after transplantation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01889576, which also lists 1 linked publication.
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 Jun 2013; AzTrials last refreshed its copy on 8 Nov 2026.