POPEYE: Oxidative Stress on Muscle Dysfunction in Hemodialysis Patient

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Terminated

CT.gov ID

NCT02794142

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Renal Failure Requiring Hemodialysis	Procedure: renal transplantation Other: No intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HD patient	Procedure: renal transplantation
Other: Healthy volunteers	Other: No intervention

Arm

Intervention/Treatment

Experimental: HD patient

Procedure: renal transplantation

Other: Healthy volunteers

Other: No intervention

Outcome Measures

Primary Outcome Measures

Muscle mitochondrial density assessed on a quadriceps biopsy by immunochemistry [2 years]

Secondary Outcome Measures

Maximum voluntary contraction of the quadriceps (in Newton.meter) [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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