SarcopeniaNCT04569487
Identification of Relevant Biological, Imaging, Mobility and Clinical Markers for Clinical Research in Sarcopenia
A study testing Biopsy in people with Sarcopenia, run by Artialis at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesBelgium
- Study dates
- 11 Feb 2021to 2 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Erasme Hospital
Brussels, 1070
Universitair Ziekenhuis Brussel
Brussels, 1090
About this study
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Biopsy
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Muscle biopsy from vastus lateralis (100-200 mg from non-dominant leg)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identified soluble markers of sarcopenia
immunoassays on biological fluids by secretomic approach
Measured: 3 months after biopsy
Secondary outcomes (9)
Identified imaging marker
Appendicular lean muscle mass and adiposity (if possible) using Dual Energy Xray Absorptiometry (DXA)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Day 0 (baseline visit)
Determine the muscle strength
Handgrip muscular strength test (upper body skeletal muscle function) using a hand dynamometer
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 3 months (baseline visit to biopsy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start11 Feb 2021
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicentric, cohort study with 2 parallel groups (sarcopenic versus non-sarcopenic population)
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artialis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yves Henrotin, Prof, Study director, Artialis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569487
- Sponsor's protocol ID
- DEMAIN
- Status last verified
- Jul 2024
- First submitted
- 24 Sep 2020
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Relevant Biological, Imaging, Mobility and Clinical Markers for Clinical Research in Sarcopenia
- ClinicalTrials.gov ID
- NCT04569487
- Acronym / sponsor ID
- DEMAIN
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- ArtialisIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicentric, cohort study with 2 parallel groups (sarcopenic versus non-sarcopenic population)
| Arm | Type | Receives |
|---|---|---|
| Sarcopenic population | Active comparator | Procedure: BiopsyDiagnosed 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 | Active comparator | Procedure: BiopsyNon-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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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
- Muscle strength assessed by the handgrip test <27 kg for male
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyMuscle biopsy from vastus lateralis (100-200 mg from non-dominant leg) | Procedure or surgery | Non sarcopenic population, Sarcopenic population |
Primary outcome
Identified soluble markers of sarcopenia
Time frame: 3 months after biopsy
immunoassays on biological fluids by secretomic approach
9 secondary outcomes
Identified imaging marker
Time frame: within 15 days after Day 0 (baseline visit)
Determine thePhysical performance
Time frame: Day 0 (baseline visit)
Determine the falls risk
Time frame: Day 0 (baseline visit)
Identified clinical marker
Time frame: Day 0 (baseline visit)
Determine the muscle strength
Time frame: Day 0 (baseline visit)
Evaluate the quality of life
Time frame: Day 0 (baseline visit)
Determine cognitive performance
Time frame: Day 0 (baseline visit)
Determine the nutrition status
Time frame: Day 0(baseline visit)
Evaluate the tolerance
Time frame: 3 months (baseline visit to biopsy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Henrotin, Prof study director
Artialis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Sarcopenia, run by Artialis at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identified soluble markers of sarcopenia (time frame: 3 months after biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.