NCT06440330招募中不适用
Define Predictors for Posttransplant Diabetes Mellitus Study
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
- 是
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
研究点 (1)
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