Oxidative Stress on Muscle Dysfunction in Hemodialysis Patient

NCT ID: NCT02794142

Last Updated: 2021-02-03

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

TERMINATED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Renal Failure Requiring Hemodialysis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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HD patient

Group Type EXPERIMENTAL

renal transplantation

Intervention Type PROCEDURE

Healthy volunteers

Group Type OTHER

No intervention

Intervention Type OTHER

Interventions

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renal transplantation

Intervention Type PROCEDURE

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Montpellier University Hospital

Montpellier, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 34750160 (View on PubMed)

Other Identifiers

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9459-2

Identifier Type: -

Identifier Source: org_study_id

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