NCT05199207

Brief Summary

Muscle failure (sarcopenia or dynapenia) is a factor of frailty and therefore, ultimately, of loss of autonomy in the elderly. Currently, no biomarker of muscle failure has a high sensitivity, specificity and positive predictive value. Several results, although preliminary, suggest that metabolomics could facilitate the early identification of frail patients, allowing the implementation of primary prevention strategies. Untargeted high-resolution metabolomics analysis would identify discriminative biomarkers and biological mechanisms associated with frailty. Finally, the hypothesis that metabolic signatures can be identified as risk factors for the development of age-related dynapenia should be tested in a longitudinal design.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2021

Completed
26 days until next milestone

Study Start

First participant enrolled

January 11, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2022

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

December 16, 2021

Last Update Submit

July 12, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Different metabolomic signature (The amino acid composition) between the sarcopenic group and the control group

    Change in the amino acid composition (metabolomic signature) at Day 0 between the sarcopenic group and the control group

    at Day 0

Secondary Outcomes (1)

  • Change in the amino acid composition (metabolomic signature) after 3 month of physical activity

    between Day 0 and Month 3

Study Arms (2)

Sarcopenic patient

EXPERIMENTAL

Patient with sarcopenic criteria (SARC-F Score, muscle strengh value, appendicular lean mass value)

Behavioral: Physical activity programm

Non sarcopenic patient

ACTIVE COMPARATOR

Patient without sarcopenic criteria (SARC-F Score, muscle strengh value, appendicular lean mass value)

Behavioral: Physical activity programm

Interventions

adapted physical activity during 3 month

Non sarcopenic patientSarcopenic patient

Eligibility Criteria

Age65 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than or equal to 65 years;
  • Patient affiliated or beneficiary of a social security plan;
  • Patient having signed a prior informed consent

You may not qualify if:

  • presence of a physical or cognitive pathology preventing the performance of the physical activity protocol during 3 months
  • Patient with legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Emeline MICHEL, MD

    Nice University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2021

First Posted

January 20, 2022

Study Start

January 11, 2022

Primary Completion

April 22, 2022

Study Completion

July 5, 2022

Last Updated

July 13, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations