About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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 design
Treatments tested in this trial
- continuous glucose monitoring
Treatment groups
Sponsors and collaborators
University Hospital, Antwerp
Lead sponsor
Universitair Ziekenhuis Brussel
Collaborator
University Ghent
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
HUB
Collaborator
Université Catholique de Louvain
Collaborator
Centre Hospitalier Universitaire de Liege
Collaborator