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

NCT02745444 | Completed

• 1 other identifier: CR_LSP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Living kidney transplantation; Chronic kidney disease; Acute kidney injury

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Change of NGAL in urine

  Preoperative from donor and receptor; 6h, 12h and 24h after renal transplantation from receptor.

• Cystatin C

  Preoperative and up until 7 days after renal transplantation from 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.

• 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.

Study Arms (4)

low-calorie formula diet

OTHER

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 diet

NO INTERVENTION

Donor ingesting food as usual.

protein-restricted diet

OTHER

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

Normal protein supply

NO INTERVENTION

Donor taking same dishes as protein-restricted diet group but with customary protein levels, with unchanged calorie supply.

Interventions

low-calorie formula diet DIETARY_SUPPLEMENT

low-calorie formula diet

protein-restricted diet DIETARY_SUPPLEMENT

protein-restricted diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University Hospital of Cologne

Cologne, 50937, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Acute Kidney Injury

Interventions

Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Volker Burst, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 20, 2016
• Study Start: April 1, 2015
• Primary Completion: May 17, 2019
• Study Completion: May 1, 2020
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

DE (1)