Define Predictors for Posttransplant Diabetes Mellitus Study

Recruiting now

Conditions studied: Post-transplant Diabetes Mellitus, Kidney Transplant; Complications

In brief

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

Key facts

Study ID

NCT06440330

Run by

University Hospital, Antwerp

People needed

330

Starts

2023-09-01

Expected to finish

2026-09-30

Last updated by the study team

2024-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UZA — Edegem, Antwerpen, Belgium (enrolling)

Full record on ClinicalTrials.gov

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