Post-transplant Diabetes MellitusDECODENCT06440330
Define Predictors for Posttransplant Diabetes Mellitus Study
An observational study of Post-transplant Diabetes Mellitus and Kidney Transplant; Complications, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The primary aim of this prospective, multicentre study is to develop an accurate and convenient tool to predict the risk of PTDM at 3 months post-transplant, based on information on the day of transplantation (day 0). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-transplant Diabetes Mellitus, Kidney Transplant; Complications
- What is being tested?
- continuous glucose monitoring
- Type of treatment
- Medical device
- How many people
- 330 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2023to 30 Sep 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Kidney transplant recipients without known pre-existing diabetes.
Who may be able to join
- Adult patients (≥18 years) with end stage kidney disease undergoing kidney transplantation with a deceased or living donor
- Signed informed consent
- Initial therapy with at least tacrolimus and corticosteroids
Who cannot join
- Patients with a diagnosis of diabetes mellitus (either type 1 or type 2) prior to kidney transplantation
- Treatment with GLP1-RA for weight losing purposes
- Patients receiving a multi-organ transplantation
- ABO incompatibility
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZA
Edegem, Antwerpen, 2650
Yassine Laghrib, MD, +3238213435, yassine.laghrib@uza.be
About this study
The primary aim of this prospective, multicentre study is to develop an accurate and convenient tool to predict the risk of PTDM at 3 months post-transplant, based on information on the day of transplantation (day 0).
In order to create such model, we will start by identifying individual predictor variables at the day of transplantation and subsequently explore the optimal combination of these predictors in multivariable models.
Read more
Secondary objectives include:
- Compare the performance of the model based on predictor variables at day 0 with existing models for prediction of PTDM (Chakkera, San Antonio Diabetes Prediction Model and Framingham Offspring Study Diabetes Mellitus algorithm)
- Explore the glucose level evolution during the first 2 weeks after transplantation using continuous glucose monitoring, and its relationship with baseline patient characteristics and immunosuppressant drug use.
- Evaluate the added value of incorporating information on glucose levels in the first and second weeks post-transplant to improve the PTDM prediction model.
- Identify predictors for early post-transplant hyperglycemia (first 2 weeks post-transplantation)
- Explore the correlation between early post-transplant hyperglycemia (fasting glycemia, pre-dinner glycemia) and PTDM at 3 months
- Being tested
- continuous glucose monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous glucose monitoringDevice
continuous glucose monitoring will be used during the first 14 days post-transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-transplant diabetes mellitus
Post-transplant diabetes mellitus diagnosis based on the need for glucose lowering therapy or 2h-OGTT value of >=200mg/dL
Measured: at 10-13 weeks post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 Sep 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-transplant Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel, University Ghent, Universitaire Ziekenhuizen KU Leuven, HUB, Université Catholique de Louvain, Centre Hospitalier Universitaire de Liege
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440330
- Sponsor's protocol ID
- 5469
- Acronym
- DECODE
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Define Predictors for Posttransplant Diabetes Mellitus Study
- ClinicalTrials.gov ID
- NCT06440330
- Acronym / sponsor ID
- DECODE / 5469
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel, University Ghent, Universitaire Ziekenhuizen KU Leuven, HUB, Université Catholique de Louvain, Centre Hospitalier Universitaire de Liege
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 3 Jun 2024 (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 primary aim of this prospective, multicentre study is to develop an accurate and convenient tool to predict the risk of PTDM at 3 months post-transplant, based on information on the day of transplantation (day 0).
In order to create such model, we will start by identifying individual predictor variables at the day of transplantation and subsequently explore the optimal combination of these predictors in multivariable models.
Secondary objectives include:
- Compare the performance of the model based on predictor variables at day 0 with existing models for prediction of PTDM (Chakkera, San Antonio Diabetes Prediction Model and Framingham Offspring Study Diabetes Mellitus algorithm)
- Explore the glucose level evolution during the first 2 weeks after transplantation using continuous glucose monitoring, and its relationship with baseline patient characteristics and immunosuppressant drug use.
- Evaluate the added value of incorporating information on glucose levels in the first and second weeks post-transplant to improve the PTDM prediction model.
- Identify predictors for early post-transplant hyperglycemia (first 2 weeks post-transplantation)
- Explore the correlation between early post-transplant hyperglycemia (fasting glycemia, pre-dinner glycemia) and PTDM at 3 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients without known pre-existing diabetes.
Key inclusion criteria (3 listed)
- Adult patients (≥18 years) with end stage kidney disease undergoing kidney transplantation with a deceased or living donor
- Signed informed consent
- Initial therapy with at least tacrolimus and corticosteroids
Key exclusion criteria (4 listed)
- Patients with a diagnosis of diabetes mellitus (either type 1 or type 2) prior to kidney transplantation
- Treatment with GLP1-RA for weight losing purposes
- Patients receiving a multi-organ transplantation
- ABO incompatibility
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 |
|---|---|---|
| continuous glucose monitoringcontinuous glucose monitoring will be used during the first 14 days post-transplantation | Device | – |
Primary outcome
Post-transplant diabetes mellitus
Time frame: at 10-13 weeks post-transplantation
Post-transplant diabetes mellitus diagnosis based on the need for glucose lowering therapy or 2h-OGTT value of >=200mg/dL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Post-transplant Diabetes Mellitus
Enrolling by invitationObservational study
Liver Transplant CGM
Liver Transplant, Post Transplant Diabetes
Not yet recruitingPhase 2
SGLT2i Effect on PTDM Development and Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients: A Randomized, Doubleblind, Placebo Controlled, National Multicenter Trial
Kidney Transplant Recipient, Sodium Glucose Co-Transporter 2 Inhibitors
Not yet recruitingObservational study
European Transplant Registry of Senior Renal Transplant Recipients on Advagraf
Graft Failure, Death
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-transplant Diabetes Mellitus and Kidney Transplant; Complications, run by University Hospital, Antwerp 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 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 3 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yassine Laghrib, MD (+3238213435, yassine.laghrib@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-transplant diabetes mellitus (time frame: at 10-13 weeks post-transplantation). 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 3 Jun 2024; AzTrials last refreshed its copy on 26 Oct 2026.