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

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Dietary Supplement: protein-restricted diet; Dietary Supplement: low-calorie formula diet

• Registration Number: NCT02745444
• Lead Sponsor: University of Cologne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-20
• Primary Completion: 2019-05-17
• Study Completion: 2020-05
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age ≥18 years
• Competent patients
• Planned living kidney transplantation
• Provision of informed consent
• BMI ≥ 18,5 kg/m²

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
protein-restricted diet	protein-restricted diet	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.
low-calorie formula diet	low-calorie formula diet	Donor taking low-calorie formula diet, 50% of basal energy rate, individually calculated with Mifflin-St. Jeor formula.

Primary Outcome Measures

Name	Time	Method
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.
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 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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

University Hospital of Cologne; 🇩🇪 Cologne, Germany