Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oxidative Stress on Muscle Dysfunction in Hemodialysis Patient (POPEYE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794142
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : June 8, 2016
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of the Oxidative Stress on the Skeletal Muscle Dysfunction in Hemodialysis Patient
Study Start Date : May 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: HD patient Procedure: renal transplantation



Primary Outcome Measures :
  1. Muscle mitochondrial density assessed on a quadriceps biopsy by immunochemistry [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Maximum voluntary contraction of the quadriceps (in Newton.meter) [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794142


Contacts
Layout table for location contacts
Contact: Farès GOUZI, MD, PhD +33 467 335 908 f-gouzi@chu-montpellier.fr

Locations
Layout table for location information
France
Montpellier University Hospital Recruiting
Montpellier, France, 34295
Contact: Farès GOUZI, MD, PhD    +33 467 335 908    f-gouzi@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02794142    
Other Study ID Numbers: 9459-2
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016
Keywords provided by University Hospital, Montpellier:
hemodialysis
muscle dysfunction
mitochondria
oxidative stress
inflammation
renal transplantation
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic