Define Predictors for Posttransplant Diabetes Mellitus Study (DECODE)

May 27, 2024 updated by: University Hospital, Antwerp

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Device: continuous glucose monitoring

Study Type

Observational

Enrollment (Estimated)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Yassine Laghrib, MD
Phone Number: +3238213435
Email: yassine.laghrib@uza.be

Study Locations

Belgium
- Antwerpen
  - Edegem, Antwerpen, Belgium, 2650
    - Recruiting
    - UZA
    - Contact:
      
      Yassine Laghrib, MD
      
      Phone Number: +3238213435
      
      Email: yassine.laghrib@uza.be

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Kidney transplant recipients without known pre-existing diabetes.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-transplant diabetes mellitus Time Frame: 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	at 10-13 weeks post-transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Collaborators

Universitaire Ziekenhuizen KU Leuven

Universitair Ziekenhuis Brussel

Université Catholique de Louvain

University Ghent

Centre Hospitalier Universitaire de Liege

HUB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

May 21, 2024

First Submitted That Met QC Criteria

May 27, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)