Define Predictors for Posttransplant Diabetes Mellitus Study

Recruiting

• Conditions: Post-transplant Diabetes Mellitus; Kidney Transplant; Complications

• Registration Number: NCT06440330
• Lead Sponsor: University Hospital, Antwerp

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-27
• Last Update Submitted: 2024-05-27
• Study First Posted: 2024-06-03
• Last Update Posted: 2024-06-03
• Primary Completion: 2026-06-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-transplant diabetes mellitus	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

Trial Locations

Locations (1)

UZA; 🇧🇪 Edegem, Antwerpen, Belgium