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

NCT04569487 | Completed

• 1 other identifier: DEMAIN
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Identified soluble markers of sarcopenia

  immunoassays on biological fluids by secretomic approach

  3 months after biopsy

Secondary Outcomes (9)

• Identified imaging marker

  within 15 days after Day 0 (baseline visit)

• Determine thePhysical performance

  Day 0 (baseline visit)

• Determine the falls risk

  Day 0 (baseline visit)

• Identified clinical marker

  Day 0 (baseline visit)

• Determine the muscle strength

  Day 0 (baseline visit)

Study Arms (2)

Sarcopenic population

ACTIVE COMPARATOR

Diagnosed sarcopenia following definition of 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

Procedure: Biopsy

Non sarcopenic population

ACTIVE COMPARATOR

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

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

Muscle biopsy from vastus lateralis (100-200 mg from non-dominant leg)

Non sarcopenic population; Sarcopenic population

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Artialis: lead

Study Sites (2)

Erasme Hospital

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yves Henrotin, Prof

  Artialis

  STUDY DIRECTOR

Study Design

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

Model Details: Prospective, multicentric, cohort study with 2 parallel groups (sarcopenic versus non-sarcopenic population)

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 30, 2020
• Study Start: February 11, 2021
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)