NCT00725166

Brief Summary

To reach the goals of living longer in better medical conditions, many countries reach the same conclusion: new strategies have to be developed to avoid, or at least limit, the effects of age; this requires a better knowledge of the mechanisms of aging. Our project focuses on the loss of muscle mass associated with aging, called sarcopenia. Sarcopenia unavoidably leads to impaired mobility and poor balance, which contributes to loss of functional autonomy and to increased prevalence for severe falls. Skeletal muscle also plays a central role as a reserve for energy and amino acids. Hence, sarcopenia further triggers severe side metabolic effects such as frailty among elderly persons. The precise mechanisms of muscle aging are still mostly unknown, although many theories have been proposed. The present study aims at better understanding the mechanisms of skeletal muscle loss associated with aging. Using muscle biopsies from young and old subjects, the differential expression profiles of mRNA will be obtained through chips that will evaluate more than 39000 transcripts. On the same samples, proteomic analyses will involve two complementary approaches: (1) bidimensional electrophoresis (2DGE) coupled to mass spectrometry (MALDI-ToF) for dominant proteins; (2) Western-blot (more than 800 antibodies) targeting regulating proteins not detectable using 2DGE. Complementary histological studies (immunohisto-fluorescence, confocal microscopy) will specify the localisation of the major biomarkers in the muscle biopsies. The results of that research will have applications in the medium term and will lead to nutritional interventions to modulate specific metabolic pathways and improve the quality of life in the elderly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2008

Shorter than P25 for all trials

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

July 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

June 11, 2009

Status Verified

June 1, 2009

Enrollment Period

5 months

First QC Date

July 29, 2008

Last Update Submit

June 9, 2009

Conditions

ElderlySarcopenia

Keywords

AgingBiopsySkeletal muscleMolecular biologyGenetic markersGene expression regulationYoung and old menHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • To identify the differential expression profiles (proteomics, transcriptomics) in skeletal muscle between young and old men

    During biopsie (W3)

Secondary Outcomes (3)

  • To specify the localisation of the major biomarkers in the muscle biopsies.

    During biopsie (W3)

  • To compare muscular energy metabolic enzymatic activities between young and old men

    during biopsie (W3)

  • To compare the number of muscular stem cells between young and old men

    during biopsie (W3)

Study Arms (2)

Young

Young men 19-25 years old

Other: Skeletal muscle aging

Old

old men 70-76 years old, who participate in the PROOF study (NCT 00759304)

Other: Skeletal muscle aging

Interventions

Skeletal muscle agingOTHER

W1 - Blood test * Maximal voluntary contraction of quadriceps * Hydrostatic weighing W2 - Maximal metabolic test using a cycloergometer W3 - Muscular biopsy

OldYoung

Eligibility Criteria

Age19 Years - 76 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Young : students of the Saint-Etienne's university. Old : men who participate in the PROOF study

You may qualify if:

  • Affiliated or beneficiary of a social security category
  • Having signed the inform consent form
  • Having signed the genetic consent form

You may not qualify if:

  • Antiaggregant platelet treatment
  • Type 2 diabetes
  • Body Mass Index \> 25
  • Severe renal disease
  • CRP \> 10
  • Abnormal clotting test
  • Allergies to local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, muscle

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Daniel BECHET, PhD

    INRA Clermont-Ferrand

    STUDY CHAIR

  • Jean-Claude BARTHELEMY, MD PhD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2008

First Posted

July 30, 2008

Study Start

October 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

June 11, 2009

Record last verified: 2009-06

Locations

FR(1)