Oxidative Stress on Muscle Dysfunction in Hemodialysis Patient

Chronic Renal Failure Requiring Hemodialysis Clinical Trial

— POPEYE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02794142
• Other study ID #: 9459-2
• Status: Terminated
• Phase: N/A
• Start date: May 2015
• Est. completion date: March 2018

Study information

• Verified date: January 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Failure Requiring Hemodialysis
• Kidney Failure, Chronic

Intervention

Procedure:
• renal transplantation

Other:
• No intervention

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle mitochondrial density assessed on a quadriceps biopsy by immunochemistry		2 years
Secondary	Maximum voluntary contraction of the quadriceps (in Newton.meter)		2 years