Predicting diabetes risk after kidney transplant
Define Predictors for Posttransplant Diabetes Mellitus Study
This study is trying to create a tool to help predict the risk of developing diabetes in people who have just received a kidney transplant by looking at their data from the day of surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 330 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem, Antwerpen) |
| Trial ID | NCT06440330 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a predictive tool for assessing the risk of post-transplant diabetes mellitus (PTDM) within three months following kidney transplantation. By analyzing data collected on the day of transplantation, researchers will identify key predictor variables and create multivariable models to enhance prediction accuracy. The study will also compare the new model's performance against existing prediction models and investigate glucose level changes in the initial weeks post-transplant. Continuous glucose monitoring will be utilized to gather detailed glucose data and its relationship with patient characteristics and immunosuppressant use.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 and older with end-stage kidney disease undergoing kidney transplantation.
Not a fit: Patients with a prior diagnosis of diabetes mellitus or those receiving multi-organ transplants will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for early identification of patients at risk for post-transplant diabetes, allowing for timely interventions.
How similar studies have performed: While there have been studies on diabetes prediction models, this approach is novel in its specific focus on post-kidney transplant patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edegem, Antwerpen
- Uza — Edegem, Antwerpen, Belgium (Recruiting)
Study contacts
- Study coordinator: Yassine Laghrib, MD
- Email: yassine.laghrib@uza.be
- Phone: +3238213435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.