The objective of this trial is to constitute a cohort of sarcopenic versus non-sarcopenic patients to validate the most relevant biological, imaging, mobility and clinical markers considered individually or in association for the diagnosis of sarcopenic patients.
This trial is part of a Research Program partly funded by a grant from the Walloon region entitled "Development of Markers of Sarcopenia Using an Integrated Approach : From Cell to Human". Consistent with the above-mentioned observation, there is not only one biological marker that perfectly matches the sarcopenia criteria but there is a range of complementary biomarkers - including but not limited to inflammation markers, products of oxidative damage, serum creatinine and urinary creatinine excretion, endocrine function, urine proteomics panel, N-terminal procollagen peptides, myostatin and agrin fragment - that will together constitute the ideal panel of markers (Fougère et al, 2015). These current biomarkers and the thresholds for correlation with clinical outcomes have to be deeply evaluated in clinical trials before being considered as good biomarkers. In addition, one research priority is to investigate and define novel biomarkers allowing an improved assessment, characterization and follow-up of elderly people with sarcopenia. Biomarkers derived from blood can indeed easily be measured in a standardized and low-cost way and are therefore very attractive. This clinical trial aims at confirming the relevance of new soluble markers and validating the most relevant biological (previously and newly identified), imaging, mobility and clinical markers for clinical research in sarcopenia. Newly identified soluble markers of sarcopenia coming from DEMAIN Research program and using secretomic approach (to be identified in secretome of human myotubes during the program research) using immunoassays on biological fluids.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
16
Muscle biopsy from vastus lateralis (100-200 mg from non-dominant leg)
Erasme Hospital
Brussels, Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium
Identified soluble markers of sarcopenia
immunoassays on biological fluids by secretomic approach
Time frame: 3 months after biopsy
Identified imaging marker
Appendicular lean muscle mass and adiposity (if possible) using Dual Energy Xray Absorptiometry (DXA)
Time frame: within 15 days after Day 0 (baseline visit)
Determine thePhysical performance
Patients realize some physical tests: Short Physical Performance Battery (SPPB that are three physical tests: gait speed, balance test, chair stand test)
Time frame: Day 0 (baseline visit)
Determine the falls risk
A global score will be calculated in function of the answers of a Self-administered questionnaire: Morse Fall Scale (MFS; falls risks for elderly)
Time frame: Day 0 (baseline visit)
Identified clinical marker
A global score will be calculated in function of the answers of a Self-administered questionnaire: SARC-F
Time frame: Day 0 (baseline visit)
Determine the muscle strength
Handgrip muscular strength test (upper body skeletal muscle function) using a hand dynamometer
Time frame: Day 0 (baseline visit)
Evaluate the quality of life
A global score will be calculated in function of the answers of a Self-administered questionnaire (SF-36). The SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
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Time frame: Day 0 (baseline visit)
Determine cognitive performance
A global score will be calculated in function of the answers of a Self-administered questionnaire: Montreal Cognitive Assessment (MoCA)
Time frame: Day 0 (baseline visit)
Determine the nutrition status
A global score will be calculated in function of the on Global Leadership Initiative on Malnutrition (GLIM) criteria (Cederholm et al, 2018)
Time frame: Day 0(baseline visit)
Evaluate the tolerance
Number of Adverse events (AE or Adverse Device Effect or Device Deficiency; will be coded in terms of System Organ Class (SOC) and Low Level Terms (LLT) using the last version of MedDRA) and drop offs
Time frame: 3 months (baseline visit to biopsy)