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Oxidative Stress on Muscle Dysfunction in Hemodialysis Patient (POPEYE)

Primary Purpose

Chronic Renal Failure Requiring Hemodialysis

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

renal transplantation

No intervention

About this trial

This is an interventional basic science trial for Chronic Renal Failure Requiring Hemodialysis focused on measuring hemodialysis, muscle dysfunction, mitochondria, oxidative stress, inflammation, renal transplantation

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age between 40-80 years old
less than 150min by week of moderate to vigorous physical activity
Chronic renal failure (glomerular filtration rate less than 15mL by min) requiring hemodialysis
Patient placed on the kidney transplant waiting list of MontpellierCHU
No indication against temporary kidney transplant
Review cardiovascular older than two years
Patient not under guardianship or trusteeship
Clinically stable state Absence or recent infection within 3 months prior to inclusion Absence of progressive neoplasia No recent acute decompensation of chronic disease (thrust of heart failure, respiratory decompensated cirrhosis).

Absence of recent stroke

musculoskeletal and neurological states of the lower limbs which allow the realization of the proposed functional tests.
Patient has given written informed consent
Absence of congenital or genetic degenerative muscle disease

Exclusion Criteria:

Terminal chronic renal failure without replacement therapy
Local anesthesic hypersensibility
Corticosteroid treatment upper than 3 month
COPD
Oral anticoagulants
Previous renal transplantation
Subject not affiliated with a social security scheme, beneficiary or not such a plan
Major subject protected by law or unable to consent under Article L 1121-8 of the Public Health Code
Vulnerable person under Article L.1121-6 of the Public Health Code

Sites / Locations

Montpellier University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

HD patient

Healthy volunteers

Arm Description

Outcomes

Primary Outcome Measures

Muscle mitochondrial density assessed on a quadriceps biopsy by immunochemistry

Secondary Outcome Measures

Maximum voluntary contraction of the quadriceps (in Newton.meter)

Full Information

NCT ID

NCT02794142

First Posted

May 26, 2016

Last Updated

January 29, 2021

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT02794142

Brief Title

Oxidative Stress on Muscle Dysfunction in Hemodialysis Patient

Acronym

POPEYE

Official Title

Impact of the Oxidative Stress on the Skeletal Muscle Dysfunction in Hemodialysis Patient

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Terminated

Why Stopped

Lack of recruitment

Study Start Date

May 2015 (Actual)

Primary Completion Date

March 2018 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

In hemodialysis patient (HD) a reduction of the skeletal muscle mass and strength has previously been reported. This muscle impairment constitutes an independent prognosis factor in HD patients. Oxidative stress and inflammation have been linked to the muscle impairment. The mitochondria is a classical producer and target of reactive oxygen species (ROS), and may thus constitute a central actor of the skeletal muscle impairment in HD patients. Therefore, the aim of the present study is to investigate the role of the muscle mitochondrial density on the muscle impairment in HD patients, in comparing the muscle mitochondrial density and oxidative stress in HD patients vs. healthy matched controls. In order to assess the effect of the oxidative stress and inflammation on the muscle impairment in HD patients, muscle function assessements will be performed after renal transplantation (which lowers the oxidative stress and inflammation levels) in the HD patient group. No therapeutic intervention will be tested in the present study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Renal Failure Requiring Hemodialysis

Keywords

hemodialysis, muscle dysfunction, mitochondria, oxidative stress, inflammation, renal transplantation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HD patient

Arm Type

Experimental

Arm Title

Healthy volunteers

Arm Type

Other

Intervention Type

Procedure

Intervention Name(s)

renal transplantation

Intervention Type

Other

Intervention Name(s)

No intervention

Primary Outcome Measure Information:

Title

Muscle mitochondrial density assessed on a quadriceps biopsy by immunochemistry

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Maximum voluntary contraction of the quadriceps (in Newton.meter)

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 40-80 years old less than 150min by week of moderate to vigorous physical activity Chronic renal failure (glomerular filtration rate less than 15mL by min) requiring hemodialysis Patient placed on the kidney transplant waiting list of MontpellierCHU No indication against temporary kidney transplant Review cardiovascular older than two years Patient not under guardianship or trusteeship Clinically stable state Absence or recent infection within 3 months prior to inclusion Absence of progressive neoplasia No recent acute decompensation of chronic disease (thrust of heart failure, respiratory decompensated cirrhosis). Absence of recent stroke musculoskeletal and neurological states of the lower limbs which allow the realization of the proposed functional tests. Patient has given written informed consent Absence of congenital or genetic degenerative muscle disease Exclusion Criteria: Terminal chronic renal failure without replacement therapy Local anesthesic hypersensibility Corticosteroid treatment upper than 3 month COPD Oral anticoagulants Previous renal transplantation Subject not affiliated with a social security scheme, beneficiary or not such a plan Major subject protected by law or unable to consent under Article L 1121-8 of the Public Health Code Vulnerable person under Article L.1121-6 of the Public Health Code

Facility Information:

Facility Name

Montpellier University Hospital

City

Montpellier

ZIP/Postal Code

34295

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

34750160

Citation

Souweine JS, Gouzi F, Badia E, Pomies P, Garrigue V, Morena M, Hayot M, Mercier J, Ayoub B, Quintrec ML, Raynaud F, Cristol JP. Skeletal Muscle Phenotype in Patients Undergoing Long-Term Hemodialysis Awaiting Kidney Transplantation. Clin J Am Soc Nephrol. 2021 Nov;16(11):1676-1685. doi: 10.2215/CJN.02390221.

Results Reference

derived

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Oxidative Stress on Muscle Dysfunction in Hemodialysis Patient

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