Prevention of Acute Kidney Injury - Molecular Mechanisms of Dietary Pre-conditioning in Human
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of differentially regulated genes on a metabolome level
研究概览
简要总结
The key objective of this pilot study is to assess the molecular mechanisms of renal pre-conditioning by a one-week low-calorie diet in humans.
The protective effect of the low-calorie diet and also of the protein-restriction in donor on transplant qualities and functions in receptor will also be investigated.
Analysis of transcriptome, lipidome, metabolome, epigenome, proteome und phosphoproteome through tissue samples as well as blood samples for comparison of low-calorie diet, protein-restriction and no-diet groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Age ≥18 years
- •Competent patients
- •Planned living kidney transplantation
- •Provision of informed consent
- •BMI ≥ 18,5 kg/m²
排除标准
- 未提供
结局指标
主要结局
Number of differentially regulated genes on a metabolome level
时间窗: up to 2 years upon receipt of the last tissue sample
Identification of relevant difference with regard to metabolome in kidney tissue between patients with low-calorie diet and and no-diet patients.
Number of differentially regulated genes on a epigenome level
时间窗: up to 2 years upon receipt of the last tissue sample
Identification of relevant difference with regard to epigenome in kidney tissue between patients with low-calorie diet and and no-diet patients.
Number of differentially regulated genes on a proteome level
时间窗: up to 1 year upon receipt of the last tissue sample
Identification of relevant difference with regard to proteome in kidney tissue between patients with low-calorie diet and and no-diet patients.
Number of differentially regulated genes on a transcriptomic level
时间窗: up to 1 year upon receipt of the last tissue sample
Identification of relevant difference with regard to transcriptome in kidney tissue between patients with low-calorie diet and and no-diet patients.
Number of differentially regulated genes on a lipidome level
时间窗: up to 2 years upon receipt of the last tissue sample
Identification of relevant difference with regard to lipidome in kidney tissue between patients with low-calorie diet and and no-diet patients.
Number of differentially regulated genes on a phosphoproteome level
时间窗: up to 2 years upon receipt of the last tissue sample
Identification of relevant difference with regard to phosphoproteome in kidney tissue between patients with low-calorie diet and and no-diet patients.
次要结局
- Cystatin C(Preoperative and up until 7 days after renal transplantation from receptor.)
- Change of NGAL in urine(Preoperative from donor and receptor; 6h, 12h and 24h after renal transplantation from receptor.)
- Occurrence of acute kidney injury(Assessed up to approx. 30 days from date of renal transplantation until date of discharge, which is the end of observation.)
- Maximum postoperative serum creatinine(Assessed up to approx. 30 days from date of renal transplantation until date of discharge, which is the end of observation.)