Define Predictors for Posttransplant Diabetes Mellitus Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Post-transplant Diabetes Mellitus Kidney Transplant; Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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continuous glucose monitoring

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes