Predicting Outcomes in Posttransplant Diabetes Mellitus Via microRNA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- To identify a panel of microRNAs at 3 months post-kidney transplant that are significantly associated with the development of PTDM within a defined follow-up period (e.g., 1 year, 2 years).
研究概览
简要总结
The study aims to improve the prediction and early detection of post-transplant diabetes mellitus (PTDM) in kidney transplant recipients. The investigators are investigating whether specific microRNA profiles measured 3 months after transplantation can reliably predict the development of PTDM within the following one to two years.
Additionally, the investigators are evaluating how traditional risk factors-such as age, immunosuppressive therapy, obesity, and infections like CMV-interact with these microRNA markers.
The ultimate goal of this research is to identify early indicators of blood sugar issues, enabling timely interventions to improve health outcomes and personalize patient care after kidney transplantation.
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
- 否
入选标准
- •Adult patients undergoing kidney transplantation.
- •Absence of pre-existing type 1 or type 2 diabetes mellitus.
- •Willingness to provide informed consent and comply with study procedures.
排除标准
- •Pre-existing type 1 or type 2 diabetes mellitus.
- •Previous organ transplantation.
- •Severe comorbidities that could confound the assessment of PTDM (e.g., pancreatic disease).
- •Inability to provide informed consent.
结局指标
主要结局
To identify a panel of microRNAs at 3 months post-kidney transplant that are significantly associated with the development of PTDM within a defined follow-up period (e.g., 1 year, 2 years).
时间窗: From enrollment to the end - 12 months
This measure quantifies the count of miRNAs that show statistically significant differential expression between patients who develop PTDM and those who do not within the follow-up period. The significance is determined based on adjusted p-values (\<0.05) and fold-change thresholds (e.g., \>2 or \<0.5). The data will be summarized as the total number of miRNAs passing these criteria for each patient group, providing a comparison of miRNA profiles at 3 months post-transplant.
次要结局
未报告次要终点
研究者
Matej Vnucak
Study coordinator
University Hospital, Martin