Oxidative Stress on Muscle Dysfunction in Hemodialysis Patient

NCT02794142 | Terminated

• 1 other identifier: 9459-2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Failure Requiring Hemodialysis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Muscle mitochondrial density assessed on a quadriceps biopsy by immunochemistry

  2 years

Secondary Outcomes (1)

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

  2 years

Study Arms (2)

HD patient

EXPERIMENTAL

Procedure: renal transplantation

Healthy volunteers

OTHER

Other: No intervention

Interventions

renal transplantation PROCEDURE

HD patient

No intervention OTHER

Healthy volunteers

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 34750160 DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Kidney Transplantation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 8, 2016
• Study Start: May 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: February 3, 2021

Record last verified: 2021-01

Locations

FR (1)