Muscle Wasting in Hemodialysis Patient
Study of Muscle Wasting Mechanisms and Biomarkers in Hemodialysis Patient
2 other identifiers
observational
40
1 country
1
Brief Summary
Muscle wasting is present in almost 50% of patients treated with chronic hemodialysis. It is associated with an increased risk of death (particularly from cardiovascular causes) and compromises quality of life (loss of autonomy and fatigue). The mechanisms leading to muscle wasting in chronic kidney disease have been the subject of several studies in animals. These have highlighted the role of the ubiquitin-proteasome system (UPS). Activation of UPS during chronic kidney disease is multifactorial. It is the result of resistance to the action of insulin/IGF1, metabolic acidosis, low grade prolonged inflammation and increased production of myostatin. To date few studies have been conducted in humans. The investigators want to identify blood markers related to muscle protein breakdown in patients undergoing hemodialysis. In parallel, the investigators want to adress the mechanisms involved in muscle proteolysis. In addition, the investigators want to identify the proteins degraded and the ubiquitination enzymes (E2/E3 couples) specifically involved in muscle loss during hemodialysis. Muscle biopsies and blood sample will beperformed during scheduled surgeries in healthy volunteers (negative control), cancer patients (positive control) or undergoing chronic hemodialysis. RNA seq analysis will be performed in blood samples and proteomic mass spectrometry analysis for establishing a specific profile between muscle and blood markers. A limited subset of blood markers common to cancer and hemodialysis atrophying muscles will be used for elaborating a chip dedicated to early detect an atrophying process. Thus, the investigators will first design a diagnostic tool for detecting non-invasively muscle protein breakdown before the onset of muscle atrophy. This will enable early and efficient nutritional counter-measures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2013
CompletedFirst Submitted
Initial submission to the registry
June 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2018
CompletedFirst Posted
Study publicly available on registry
July 11, 2018
CompletedJuly 12, 2018
June 1, 2018
4.1 years
June 28, 2018
July 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Transcriptomic analysis of total blood sample
Total RNA will be extracted from blood using Paxgene RNA Extraction kit and analysed by RNAseq and a comparison made between patients and control.
From July 2009 to July 2011
To find biomarkers of muscle atrophy
1. To confirm the implication of UPS in muscular proteolysis of IRCH patients by the detection of an increasing of ARNm, except ubiquitin, implicated in the quantitative RT-PCR system and by the identification of substrates. 2. To locate on the proteins that have to be deteriorated, the sites used by the UPS to fix polyubiquitin chains.
From July 2009 to July 2011
Secondary Outcomes (2)
Transcriptomic analysis
From July 2009 to July 2011
Proteomic analysis in muscle biopsies for identification of cachexia mechanism
From July 2009 to July 2011
Study Arms (3)
healthy volunteers
cancer patients
undergoing chronic hemodialysis patients
Interventions
No intervention
Eligibility Criteria
Both female and male participants from18 years old to 75 years old are being studied. Those 40 patients are either affected by cancer or hemodialysis volunteer, or constitute group control.
You may qualify if:
- over 18 years old,
- with either newly diagnosed lung cancer (for whom surgical resection was programmed by thoracotomy) or patients with end-stage renal failure treated for at least 6 months by hemodialysis and necessitating femoral bypass revascularization.
- The control group patients required hip replacement for osteoarthritis.
You may not qualify if:
- acute or chronic infections,
- diabetes mellitus,
- corticosteroid or hormone therapy or
- pregnancy.
- Glomerular filtration rate \< 90 mL/min for LC and CT patients
- active neoplasia in patients of the HD and CT groups
- CRP \> 3 mg/L in for CT patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julien ANIORT
University Hospital, Clermont-Ferrand
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2018
First Posted
July 11, 2018
Study Start
July 1, 2009
Primary Completion
July 31, 2013
Study Completion
June 28, 2018
Last Updated
July 12, 2018
Record last verified: 2018-06