Clinical Trial

Define Predictors for Posttransplant Diabetes Mellitus Study

Study acronym: DECODE
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated June 3, 2024 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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). 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
Trial Details
NCT Number NCT06440330
Lead Sponsor University Hospital, Antwerp
Collaborators: Universitair Ziekenhuis Brussel, University Ghent, Universitaire Ziekenhuizen KU Leuven, HUB, Université Catholique de Louvain, Centre Hospitalier Universitaire de Liege
Conditions Post-transplant Diabetes Mellitus, Kidney Transplant; Complications
Enrollment 330 participants
Start Date 2023-09-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2024-06-03