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

Primary Purpose

Sarcopenia

Status

Recruiting

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Biopsy

About this trial

This is an interventional diagnostic trial for Sarcopenia

Eligibility Criteria

65 Years - undefined (Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Erasme HospitalRecruiting
Universitair Ziekenhuis BrusselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Sarcopenic population

Non sarcopenic population

Arm Description

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

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

Outcomes

Primary Outcome Measures

Identified soluble markers of sarcopenia

immunoassays on biological fluids by secretomic approach

Secondary Outcome Measures

Identified imaging marker

Appendicular lean muscle mass and adiposity (if possible) using Dual Energy Xray Absorptiometry (DXA)

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)

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)

Identified clinical marker

A global score will be calculated in function of the answers of a Self-administered questionnaire: SARC-F

Determine the muscle strength

Handgrip muscular strength test (upper body skeletal muscle function) using a hand dynamometer

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.

Determine cognitive performance

A global score will be calculated in function of the answers of a Self-administered questionnaire: Montreal Cognitive Assessment (MoCA)

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)

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

Full Information

NCT ID

NCT04569487

First Posted

September 24, 2020

Last Updated

July 24, 2023

Sponsor

Artialis

1. Study Identification

Unique Protocol Identification Number

NCT04569487

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 11, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Artialis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcopenia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sarcopenic population

Arm Type

Active Comparator

Arm Description

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

Arm Title

Non sarcopenic population

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Biopsy

Intervention Description

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

Primary Outcome Measure Information:

Title

Identified soluble markers of sarcopenia

Description

immunoassays on biological fluids by secretomic approach

Time Frame

3 months after biopsy

Secondary Outcome Measure Information:

Title

Identified imaging marker

Description

Appendicular lean muscle mass and adiposity (if possible) using Dual Energy Xray Absorptiometry (DXA)

Time Frame

within 15 days after Day 0 (baseline visit)

Title

Determine thePhysical performance

Description

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)

Title

Determine the falls risk

Description

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)

Title

Identified clinical marker

Description

A global score will be calculated in function of the answers of a Self-administered questionnaire: SARC-F

Time Frame

Day 0 (baseline visit)

Title

Determine the muscle strength

Description

Handgrip muscular strength test (upper body skeletal muscle function) using a hand dynamometer

Time Frame

Day 0 (baseline visit)

Title

Evaluate the quality of life

Description

Time Frame

Day 0 (baseline visit)

Title

Determine cognitive performance

Description

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)

Title

Determine the nutrition status

Description

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)

Title

Evaluate the tolerance

Description

Time Frame

3 months (baseline visit to biopsy)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yves Henrotin, Prof

Phone

0032 4 242 77 06

yves.henrotin@artialis.com

First Name & Middle Initial & Last Name or Official Title & Degree

Bérénice Coste, PhD

Phone

0032 4 242 77 47

berenice.costes@artialis.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yves Henrotin, Prof

Organizational Affiliation

Artialis

Official's Role

Study Director

Facility Information:

Facility Name

Erasme Hospital

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sandra De Breucker, MD

Facility Name

Universitair Ziekenhuis Brussel

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ivan Bautmans, MD, Phd

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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