ElderlyCERANCT00725166
Human Muscle Gene Expression Profiles in Young and Old Men
An observational study of Elderly and Sarcopenia, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 19 to 76 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Elderly, Sarcopenia
- What is being tested?
- Skeletal muscle aging
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 76 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Young : students of the Saint-Etienne's university. Old : men who participate in the PROOF study
Who may be able to join
- Affiliated or beneficiary of a social security category
- Having signed the inform consent form
- Having signed the genetic consent form
Who cannot join
- Antiaggregant platelet treatment
- Type 2 diabetes
- Body Mass Index > 25
- Severe renal disease
- CRP > 10
- Abnormal clotting test
- Allergies to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Elderly, Sarcopenia
- Being tested
- Skeletal muscle aging
- Keywords
- Aging, Biopsy, Skeletal muscle, Molecular biology, Genetic markers, Gene expression regulation, Young and old men, Healthy volunteers
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skeletal muscle agingOther
W1 - Blood test
- Maximal voluntary contraction of quadriceps
- Hydrostatic weighing
W2 - Maximal metabolic test using a cycloergometer
W3 - Muscular biopsy
| Study group | Role | What they receive |
|---|---|---|
| Young | Young men 19-25 years old Receives: Other: Skeletal muscle aging | |
| Old | old men 70-76 years old, who participate in the PROOF study (NCT 00759304) Receives: Other: Skeletal muscle aging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the differential expression profiles (proteomics, transcriptomics) in skeletal muscle between young and old men
Measured: During biopsie (W3)
Secondary outcomes (3)
To specify the localisation of the major biomarkers in the muscle biopsies.
Measured: During biopsie (W3)
To compare muscular energy metabolic enzymatic activities between young and old men
Measured: during biopsie (W3)
To compare the number of muscular stem cells between young and old men
Measured: during biopsie (W3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation des Caisses d'Epargne Rhône-Alpes, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Investigators
- Daniel BECHET, PhD, Study chair, INRA Clermont-FerrandJean-Claude BARTHELEMY, MD PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725166
- Sponsor's protocol ID
- 0708102
- Other IDs
- 2008-A00374-51
- Acronym
- CERA
- Status last verified
- Jun 2009
- First submitted
- 29 Jul 2008
- Last updated
- 11 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Muscle Gene Expression Profiles in Young and Old Men
- ClinicalTrials.gov ID
- NCT00725166
- Acronym / sponsor ID
- CERA / 0708102
- Conditions
- Elderly, Sarcopenia
- Keywords
- Aging, Biopsy, Skeletal muscle, Molecular biology, Genetic markers, Gene expression regulation, Young and old men, Healthy volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Fondation des Caisses d'Epargne Rhône-Alpes, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 30 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young | – | Other: Skeletal muscle agingYoung men 19-25 years old |
| Old | – | Other: Skeletal muscle agingold men 70-76 years old, who participate in the PROOF study (NCT 00759304) |
Who may qualify
- Ages
- 19 to 76 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Young : students of the Saint-Etienne's university. Old : men who participate in the PROOF study
Key inclusion criteria (3 listed)
- Affiliated or beneficiary of a social security category
- Having signed the inform consent form
- Having signed the genetic consent form
Key exclusion criteria (7 listed)
- Antiaggregant platelet treatment
- Type 2 diabetes
- Body Mass Index > 25
- Severe renal disease
- CRP > 10
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skeletal muscle agingW1 - Blood test * Maximal voluntary contraction of quadriceps * Hydrostatic weighing W2 - Maximal metabolic test using a cycloergometer W3 - Muscular biopsy | Other | Old, Young |
Primary outcome
To identify the differential expression profiles (proteomics, transcriptomics) in skeletal muscle between young and old men
Time frame: During biopsie (W3)
3 secondary outcomes
To specify the localisation of the major biomarkers in the muscle biopsies.
Time frame: During biopsie (W3)
To compare muscular energy metabolic enzymatic activities between young and old men
Time frame: during biopsie (W3)
To compare the number of muscular stem cells between young and old men
Time frame: during biopsie (W3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel BECHET, PhD study chair
INRA Clermont-Ferrand
Jean-Claude BARTHELEMY, MD PhD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly and Sarcopenia, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the differential expression profiles (proteomics, transcriptomics) in skeletal muscle between young and old men (time frame: During biopsie (W3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2009.