Actively Recruiting
Define Predictors for Posttransplant Diabetes Mellitus Study
Led by University Hospital, Antwerp · Updated on 2024-06-03
330
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Antwerp
Lead Sponsor
U
Universitair Ziekenhuis Brussel
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, multicenter observational study to develop a tool that predicts the risk of post-transplant diabetes mellitus (PTDM) three months after kidney transplantation. The study aims to identify individual predictor variables on the day of transplantation and explore optimal combinations in predictive models. It also compares the new model with existing PTDM prediction models and investigates glucose level changes in the first two weeks post-transplant. Participants will undergo continuous glucose monitoring for the first 14 days after transplantation to track glucose levels. The study will analyze how these glucose patterns relate to baseline patient characteristics and immunosuppressant drug use. Researchers will evaluate whether adding glucose data from the early post-transplant period improves prediction accuracy and will identify predictors for early hyperglycemia. During the study, participants will be monitored for the development of PTDM at 10 to 13 weeks post-transplant. Data collection includes baseline information on transplantation day and glucose monitoring results. The study includes adult kidney transplant recipients receiving immunosuppressive therapy with tacrolimus and corticosteroids. The overall follow-up and participation duration align with the primary outcome assessment at about three months post-transplant.
CONDITIONS
Brief Title
Define Predictors for Posttransplant Diabetes Mellitus Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (18 years or older) 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants have continuous glucose monitoring during the first 14 days after transplantation.
Continuous monitoring during hospital stay
Duration - 10 to 13 weeks
Participants are monitored for the development of post-transplant diabetes mellitus up to 10 to 13 weeks after transplantation.
Follow-up visits as scheduled up to 13 weeks post-transplant
Trial Site Locations
Total: 1 location
1
UZA
Edegem, Antwerpen, Belgium, 2650
Actively Recruiting
Research Team
Y
Yassine Laghrib, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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