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

University of Cologne40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Chronic Kidney Disease

Interventions

low-calorie formula dietDIETARY_SUPPLEMENT

protein-restricted dietDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of Cologne

Cologne, Germany

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: up to 2 years upon receipt of the last tissue sample

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Change of NGAL in urine

Change of NGAL in urine, marker for kidney damage measured preoperative in donor and receptor.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Assessed up to approx. 30 days from date of renal transplantation until date of discharge, which is the end of observation.