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Define Predictors for Posttransplant Diabetes Mellitus Study (DECODE) 330

Recruiting
Clinical Trial NCT06440330 (DECODE) is an observational study for Post-transplant Diabetes Mellitus, Kidney Transplant; Complications that is recruiting. It started on 1 September 2023 with plans to enroll 330 participants. Led by University Hospital, Antwerp, it is expected to complete by 30 September 2026. The latest data from ClinicalTrials.gov was last updated on 3 June 2024.
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 multivar...

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Official Title

Define Predictors for Posttransplant Diabetes Mellitus Study

Conditions
Post-transplant Diabetes MellitusKidney Transplant; Complications
Other Study IDs
  • DECODE
  • 5469
NCT ID Number
Start Date (Actual)
2023-09-01
Last Update Posted
2024-06-03
Completion Date (Estimated)
2026-09-30
Enrollment (Estimated)
330
Study Type
Observational
Status
Recruiting
Arms / Interventions
Participant Group/ArmIntervention/Treatment
N/A
continuous glucose monitoring
continuous glucose monitoring will be used during the first 14 days post-transplantation
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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

  • 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
University Hospital, Antwerp logoUniversity Hospital, Antwerp
  • �...
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Study Central Contact
Contact: Yassine Laghrib, MD, +3238213435, [email protected]
1 Study Locations in 1 Countries

Antwerpen

UZA, Edegem, Antwerpen, 2650, Belgium
Yassine Laghrib, MD, Contact, +3238213435, [email protected]
Recruiting