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NCT Number: NCT06440330

Define Predictors for Posttransplant Diabetes Mellitus Study

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous glucose monitoring

Device

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

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Yassine Laghrib, MD

CONTACT

[email protected]

+3238213435

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Centre Hospitalier Universitaire de Liege
  • HUB
  • Universitair Ziekenhuis Brussel
  • Universitaire Ziekenhuizen KU Leuven
  • University Ghent
  • Université Catholique de Louvain

Registry information

Acronym: DECODE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2024
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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