Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440330
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-21
Brief Title:
Define Predictors for Posttransplant Diabetes Mellitus Study
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Define Predictors for Posttransplant Diabetes Mellitus Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DECODE
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None