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Define Predictors for Posttransplant Diabetes Mellitus Study

NCT06440330 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2024-06-03

No results posted yet for this study

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

DEVICE

continuous glucose monitoring

continuous glucose monitoring will be used during the first 14 days post-transplantation

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    collaborator OTHER

  • University Ghent

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • HUB

    collaborator UNKNOWN

  • Université Catholique de Louvain

    collaborator OTHER

  • Centre Hospitalier Universitaire de Liege

    collaborator OTHER

  • University Hospital, Antwerp

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2026-06-30
Completion
2026-09-30
FDA Device
Yes

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06440330 on ClinicalTrials.gov