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临床试验/NCT06440330
NCT06440330招募中不适用

Define Predictors for Posttransplant Diabetes Mellitus Study

University Hospital, Antwerp1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
330
试验地点
1
主要终点
Post-transplant diabetes mellitus

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Post-transplant diabetes mellitus

时间窗: at 10-13 weeks post-transplantation

Post-transplant diabetes mellitus diagnosis based on the need for glucose lowering therapy or 2h-OGTT value of \>=200mg/dL

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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