NCT06440330

Define Predictors for Posttransplant Diabetes Mellitus Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 330 (estimated)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Post-transplant Diabetes Mellitus
• Kidney Transplant; Complications

Interventions

Type	Name	Description
DEVICE	continuous glucose monitoring	continuous glucose monitoring will be used during the first 14 days post-transplantation

Timeline

• Start date: 2023-09-01
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2024-06-03
• Last updated: 2024-06-03

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated device study