Identification of Relevant Biological, Imaging, Mobility and Clinical Markers for Clinical Research in Sarcopenia

Sarcopenia Clinical Trial

Official title:

Identification of Relevant Biological, Imaging, Mobility and Clinical Markers for Clinical Research in Sarcopenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04569487
• Other study ID #: DEMAIN
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Artialis
• Contact: Yves Henrotin, Prof
• Phone: 0032 4 242 77 06
• Email: yves.henrotin[@]artialis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

Participants will have the following inclusion criteria:

• Male with age = 65 years

• Body Mass Index: 20 < BMI < 35 kg/m2

• Able to understand and having signed an informed consent

• Able to follow the trial procedures

Sarcopenic population: diagnosed sarcopenia following definition of the EWGSOP2:

• Muscle strength assessed by the handgrip test <27 kg for male

• Skeletal muscle mass index (Appendicular lean muscle mass) assessed by DXA <7.0 kg/m2

Non-sarcopenic population: adapted from the EWGSOP2:

• Muscle strength assessed by the handgrip test = 27 kg

• Skeletal muscle mass index (Appendicular lean muscle mass) assessed by DXA = 7.0 kg/m2

Exclusion Criteria:

Participants will have the following exclusion criteria:

• Any clinically significant levels of the safety parameters (Creatine Kinase (CK), activated Partial Thromboplastin Time (aPTT), Prothrombin Time and International Normalized Ratio (PT/INR))

• Any severe, uncontrolled and limiting diseases (e.g. systemic inflammation, infectious diseases, active cancer, neurodegenerative disorders, diabetes) left to the investigator's discretion

• Bed resting for more than 10 days during the 3 months preceding the recruitment

• Immobilization of the lower limb, lasting more than one week during the 3 months preceding recruitment

• Medical treatment with anticoagulant, insulin, immunosuppressant, long-term corticosteroid (over 7.5 mg prednisone or its equivalent)

• Severe incapacity (class IV Steinbrocker Functional Classification - Appendix 2)

• Any treatment that may affect physical performance, muscle function, disrupts study measures or impairs the understanding of consent

• Known acute or severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73m2)

• Cushing' syndrome

• Known cachexia

• Currently participating or having participated in another therapeutic clinical trial in the three previous months

• Under guardianship or judicial protection

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Procedure:
• Biopsy
Muscle biopsy from vastus lateralis (100-200 mg from non-dominant leg)

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussel
Belgium	Erasme Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Artialis

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identified soluble markers of sarcopenia	immunoassays on biological fluids by secretomic approach	3 months after biopsy
Secondary	Identified imaging marker	Appendicular lean muscle mass and adiposity (if possible) using Dual Energy Xray Absorptiometry (DXA)	within 15 days after Day 0 (baseline visit)
Secondary	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)	Day 0 (baseline visit)
Secondary	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)	Day 0 (baseline visit)
Secondary	Identified clinical marker	A global score will be calculated in function of the answers of a Self-administered questionnaire: SARC-F	Day 0 (baseline visit)
Secondary	Determine the muscle strength	Handgrip muscular strength test (upper body skeletal muscle function) using a hand dynamometer	Day 0 (baseline visit)
Secondary	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.	Day 0 (baseline visit)
Secondary	Determine cognitive performance	A global score will be calculated in function of the answers of a Self-administered questionnaire: Montreal Cognitive Assessment (MoCA)	Day 0 (baseline visit)
Secondary	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)	Day 0(baseline visit)
Secondary	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	3 months (baseline visit to biopsy)