Human Muscle Gene Expression Profiles in Young and Old Men

Sarcopenia Clinical Trial

— CERA  

Official title:

Human Muscle Gene Expression Profiles in Young and Old Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725166
• Other study ID #: 0708102
• Secondary ID: 2008-A00374-51
• Status: Completed
• Phase: N/A
• First received: July 29, 2008
• Last updated: June 9, 2009
• Start date: October 2008
• Est. completion date: March 2009

Study information

• Verified date: June 2009
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthFrance: Direction Générale de la SantéFrance: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 76 Years

Eligibility

Inclusion Criteria:

• Affiliated or beneficiary of a social security category

• Having signed the inform consent form

• Having signed the genetic consent form

Exclusion Criteria:

• Antiaggregant platelet treatment

• Type 2 diabetes

• Body Mass Index > 25

• Severe renal disease

• CRP > 10

• Abnormal clotting test

• Allergies to local anesthetics

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Elderly
• Sarcopenia

Intervention

Other:
• Skeletal muscle aging
W1 - Blood test Maximal voluntary contraction of quadriceps Hydrostatic weighing W2 - Maximal metabolic test using a cycloergometer W3 - Muscular biopsy

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-etienne

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Fondation des Caisses d'Epargne Rhône-Alpes, Institut National de la Recherche Agronomique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify the differential expression profiles (proteomics, transcriptomics) in skeletal muscle between young and old men		During biopsie (W3)	No
Secondary	To specify the localisation of the major biomarkers in the muscle biopsies.		During biopsie (W3)	No
Secondary	To compare muscular energy metabolic enzymatic activities between young and old men		during biopsie (W3)	No
Secondary	To compare the number of muscular stem cells between young and old men		during biopsie (W3)	No