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

NCT ID: NCT02745444

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2020-05-31

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.

Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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low-calorie formula diet

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

Group Type OTHER

low-calorie formula diet

Intervention Type DIETARY_SUPPLEMENT

no diet

Donor ingesting food as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type OTHER

protein-restricted diet

Intervention Type DIETARY_SUPPLEMENT

Normal protein supply

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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low-calorie formula diet

Intervention Type DIETARY_SUPPLEMENT

protein-restricted diet

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Volker Burst

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Volker Burst, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

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University Hospital of Cologne

Cologne, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CR_LSP

Identifier Type: -

Identifier Source: org_study_id

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