Prevention of Acute Kidney Injury - Molecular Mechanisms of Dietary Pre-conditioning in Human

Study Overview
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Brief Summary
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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.

Official Title
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Prevention of Acute Kidney Injury - Molecular Mechanisms of Dietary Pre-conditioning in Human

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Dietary Supplement: low-calorie formula diet
* Dietary Supplement: protein-restricted diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Competent patients Planned living kidney transplantation Provision of informed consent BMI ≥ 18,5 kg/m² Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: low-calorie formula diet<br>Donor taking low-calorie formula diet, 50% of basal energy rate, individually calculated with Mifflin-St. Jeor formula. | Dietary Supplement: low-calorie formula diet<br> <br> |
| No Intervention: no diet<br>Donor ingesting food as usual. | |
| Other: protein-restricted diet<br>Donor taking protein-restricted diet according to diet plans of clinical dietetics of University Hospital of Cologne, with unchanged calorie supply, individually calculated with Mifflin-St. Jeor formula. | Dietary Supplement: protein-restricted diet<br> <br> |
| No Intervention: Normal protein supply<br>Donor taking same dishes as protein-restricted diet group but with customary protein levels, with unchanged calorie supply. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of differentially regulated genes on a transcriptomic level | Identification of relevant difference with regard to transcriptome in kidney tissue between patients with low-calorie diet and and no-diet patients. | up to 1 year upon receipt of the last tissue sample | 
| Number of differentially regulated genes on a lipidome level | Identification of relevant difference with regard to lipidome in kidney tissue between patients with low-calorie diet and and no-diet patients. | up to 2 years upon receipt of the last tissue sample | 
| Number of differentially regulated genes on a metabolome level | Identification of relevant difference with regard to metabolome in kidney tissue between patients with low-calorie diet and and no-diet patients. | up to 2 years upon receipt of the last tissue sample | 
| Number of differentially regulated genes on a epigenome level | Identification of relevant difference with regard to epigenome in kidney tissue between patients with low-calorie diet and and no-diet patients. | up to 2 years upon receipt of the last tissue sample | 
| Number of differentially regulated genes on a proteome level | Identification of relevant difference with regard to proteome in kidney tissue between patients with low-calorie diet and and no-diet patients. | up to 1 year upon receipt of the last tissue sample | 
| Number of differentially regulated genes on a phosphoproteome level | Identification of relevant difference with regard to phosphoproteome in kidney tissue between patients with low-calorie diet and and no-diet patients. | up to 2 years upon receipt of the last tissue sample | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of NGAL in urine | Change of NGAL in urine, marker for kidney damage measured preoperative in donor and receptor. | Preoperative from donor and receptor; 6h, 12h and 24h after renal transplantation from receptor. | 
| Cystatin C | Marker for kidney damage measured preoperative and daily until Day 7 postoperative in receptor. | Preoperative and up until 7 days after renal transplantation from receptor. | 
| Occurrence of acute kidney injury | Occurrence of acute kidney injury according to KDIGO I, II, III in receptor. | 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 | Maximum postoperative serum creatinine of receptor during hospital stay. | Assessed up to approx. 30 days from date of renal transplantation until date of discharge, which is the end of observation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Living kidney transplantation, Chronic kidney disease, Acute kidney injury