Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06440330

Define Predictors for Posttransplant Diabetes Mellitus Study

Led by University Hospital, Antwerp · Updated on 2024-06-03

330

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Antwerp

Lead Sponsor

U

Universitair Ziekenhuis Brussel

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Define Predictors for Posttransplant Diabetes Mellitus Study

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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+1

Trial Site Locations

Total: 1 location

1

UZA

Edegem, Antwerpen, Belgium, 2650

Actively Recruiting

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Research Team

Y

Yassine Laghrib, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Define Predictors for Posttransplant Diabetes Mellitus Study | DecenTrialz