NCT06440330 Define Predictors for Posttransplant Diabetes Mellitus Study
| NCT ID | NCT06440330 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Antwerp |
| Condition | Post-transplant Diabetes Mellitus |
| Study Type | OBSERVATIONAL |
| Enrollment | 330 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 330 participants in total. It began in 2023-09-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06440330 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post-transplant Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06440330 currently recruiting?
Yes, NCT06440330 is actively recruiting participants. Contact the research team at yassine.laghrib@uza.be for enrollment information.
Where is the NCT06440330 trial being conducted?
This trial is being conducted at Edegem, Belgium.
Who is sponsoring the NCT06440330 clinical trial?
NCT06440330 is sponsored by University Hospital, Antwerp. The trial plans to enroll 330 participants.
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