Define Predictors for Posttransplant Diabetes Mellitus Study

Kidney Transplant; Complications Clinical Trial

— DECODE  

Official title:

Define Predictors for Posttransplant Diabetes Mellitus Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06440330
• Other study ID #: 5469
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Antwerp
• Contact: Yassine Laghrib, MD
• Phone: +3238213435
• Email: yassine.laghrib[@]uza.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: September 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Kidney Transplant; Complications
• Post-transplant Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Belgium	UZA	Edegem	Antwerpen

Sponsors (7)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Centre Hospitalier Universitaire de Liege, HUB, Universitair Ziekenhuis Brussel, Universitaire Ziekenhuizen KU Leuven, Université Catholique de Louvain, University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-transplant diabetes mellitus	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