NCT02675192

Brief Summary

Aging affects almost all the tissues and physiological functions, and skeletal muscle is the most affected organ. The progressive decline of the weight and the muscular function linked to the aging contributes to the lack of autonomy and dependence, but also to an increase of the mortality risks. Sarcopenia is also a prevalent condition, because it is detected in 13-24% of 60 years old, and 50% of 80 years old and more. However, strong inter-individual variations of this prevalence of sarcopenia exists. The key issue is to understand why the biological aging of the skeletal muscle is so different between people. In this study, mechanisms involved in biological aging of the skeletal muscle in aging people (same chronological age) will be specified.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

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

January 25, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

February 18, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2017

Completed
Last Updated

November 17, 2021

Status Verified

May 1, 2021

Enrollment Period

11 months

First QC Date

January 25, 2016

Last Update Submit

November 16, 2021

Conditions

HEALTHY

Keywords

sarcopeniaelderlymuscle biopsy

Outcome Measures

Primary Outcomes (1)

  • The area of type IIA fibers called vastus lateralis.

    The primary endpoint is the cross sectional area (measured in µm2) of type IIA fibers from the vastus lateralis muscle biopsies.

    Day 15

Study Arms (1)

Proof cohort : muscular assessment

* Clinical examination : Body weight, BMI, cardiac frequency, muscular examination,... * Blood appraisal : glycaemia, lipidic appraisal, leptin, albumin, coagulation, metabolome and epigenetic tests,... * Urinary collection : metabolome tests * Maximal voluntary quadriceps strength (MVC) * Checking muscle functional skills * Muscular biopsy

Other: Proof cohort : muscular assessment

Interventions

Proof cohort : muscular assessmentOTHER

Clinical examination, blood appraisal, urinary collection, MVC, checking muscle functional skills and muscular biopsy will be performed.

Proof cohort : muscular assessment

Eligibility Criteria

Age80 Years - 83 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients are recruited in the Proof cohort (Barthélemy et al., 2007).

You may qualify if:

  • Belonging to the Proof cohort
  • Between 80 and 83 years old
  • Informed consent signed
  • Genetic analyses consent signed
  • Subject affiliated or entitled to a social security scheme

You may not qualify if:

  • Anti coagulative treatment
  • Severe obesity (\>35)
  • All chronic pathology requiring a treatment
  • Severe renal insufficiency (discovery less than 6 months)
  • Abnormal coagulation appraisal
  • Allergy to local anesthetics
  • Installation of a prosthetic hip and / or knee in the last six months
  • Senile dementia
  • Refusal of genetic study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint Etienne

Saint-Etienne, 42100, France

Location

Related Publications (1)

  • Barthelemy JC, Pichot V, Dauphinot V, Celle S, Laurent B, Garcin A, Maudoux D, Kerleroux J, Lacour JR, Kossovsky M, Gaspoz JM, Roche F. Autonomic nervous system activity and decline as prognostic indicators of cardiovascular and cerebrovascular events: the 'PROOF' Study. Study design and population sample. Associations with sleep-related breathing disorders: the 'SYNAPSE' Study. Neuroepidemiology. 2007;29(1-2):18-28. doi: 10.1159/000108914.

    PMID: 17898520BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urinary and blood samples will be taken, and a muscle biopsy will be performed.

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

  • FEASSON Léonard, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2016

First Posted

February 5, 2016

Study Start

February 18, 2016

Primary Completion

January 20, 2017

Study Completion

May 23, 2017

Last Updated

November 17, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)