Define Predictors for Posttransplant Diabetes Mellitus Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06440330

Acronym

DECODE

Enrollment

330

Registered

2024-06-03

Start date

2023-09-01

Completion date

2026-09-30

Last updated

2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant; Complications, Post-transplant Diabetes Mellitus

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

Interventions

DEVICEcontinuous glucose monitoring

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Belgium

Contacts

Primary ContactYassine Laghrib, MD

yassine.laghrib@uza.be+3238213435

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026