Chronic Kidney Disease
Conditions
Keywords
Living kidney transplantation, Chronic kidney disease, Acute kidney injury
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTlow-calorie formula diet
DIETARY_SUPPLEMENTprotein-restricted diet
Sponsors
University of Cologne
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Competent patients * Planned living kidney transplantation * Provision of informed consent * BMI ≥ 18,5 kg/m²
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of differentially regulated genes on a phosphoproteome level | 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. |
| Number of differentially regulated genes on a lipidome level | 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 metabolome level | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cystatin C | Preoperative and up until 7 days after renal transplantation from receptor. | Marker for kidney damage measured preoperative and daily until Day 7 postoperative in 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. | Occurrence of acute kidney injury according to KDIGO I, II, III in receptor. |
| 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. | Maximum postoperative serum creatinine of receptor during hospital stay. |
| Change of NGAL in urine | Preoperative from donor and receptor; 6h, 12h and 24h after renal transplantation from receptor. | Change of NGAL in urine, marker for kidney damage measured preoperative in donor and receptor. |
Countries
Germany
Outcome results
None listed