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

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 Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Dietary supplement: low-calorie formula diet; Dietary supplement: protein-restricted diet

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50937
    • University Hospital of Cologne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: low-calorie formula diet; Donor taking low-calorie formula diet, 50% of basal energy rate, individually calculated with Mifflin-St. Jeor formula.	Dietary supplement: low-calorie formula diet
No Intervention: no diet; Donor ingesting food as usual.
Other: 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.	Dietary supplement: protein-restricted diet
No Intervention: Normal protein supply; Donor taking same dishes as protein-restricted diet group but with customary protein levels, with unchanged calorie supply.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Cologne
• Investigators: Principal Investigator: Volker Burst, MD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): May 17, 2019
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: March 29, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Chronic kidney disease; Acute kidney injury; Living kidney transplantation
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury
• Other Study ID Numbers: CR_LSP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED