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

July 30, 2024 updated by: Artialis
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Brussel, Belgium, 1090
        • Universitair Ziekenhuis Brussel
      • Brussels, Belgium, 1070
        • Erasme Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Sarcopenic population

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
Muscle biopsy from vastus lateralis (100-200 mg from non-dominant leg)
Active Comparator: Non sarcopenic population

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Identified soluble markers of sarcopenia
Time Frame: 3 months after biopsy
immunoassays on biological fluids by secretomic approach
3 months after biopsy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Identified imaging marker
Time Frame: within 15 days after Day 0 (baseline visit)
Appendicular lean muscle mass and adiposity (if possible) using Dual Energy Xray Absorptiometry (DXA)
within 15 days after Day 0 (baseline visit)
Determine thePhysical performance
Time Frame: Day 0 (baseline visit)
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)
Determine the falls risk
Time Frame: Day 0 (baseline visit)
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)
Identified clinical marker
Time Frame: Day 0 (baseline visit)
A global score will be calculated in function of the answers of a Self-administered questionnaire: SARC-F
Day 0 (baseline visit)
Determine the muscle strength
Time Frame: Day 0 (baseline visit)
Handgrip muscular strength test (upper body skeletal muscle function) using a hand dynamometer
Day 0 (baseline visit)
Evaluate the quality of life
Time Frame: Day 0 (baseline visit)
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)
Determine cognitive performance
Time Frame: Day 0 (baseline visit)
A global score will be calculated in function of the answers of a Self-administered questionnaire: Montreal Cognitive Assessment (MoCA)
Day 0 (baseline visit)
Determine the nutrition status
Time Frame: Day 0(baseline visit)
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)
Evaluate the tolerance
Time Frame: 3 months (baseline visit to biopsy)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Artialis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yves Henrotin, Prof, Artialis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DEMAIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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