HEALTHYBioAgeNCT02675192
Biological Aging of Skeletal Muscles in Humans
An observational study of HEALTHY, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 to 83 yearsHealthy volunteers can take part
- Conditions the study is for
- HEALTHY
- What is being tested?
- Proof cohort : muscular assessment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2016to 23 May 2017
- 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 80 to 83 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients are recruited in the Proof cohort (Barthélemy et al., 2007).
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Installation of a prosthetic hip and / or knee in the last six months
- Senile dementia
- Refusal of genetic study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biological Aging of Skeletal Muscles in Humans, a Monocentric, Prospective Study
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.
Read the detailed description
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. Some elderly (60 years old) reveal a biological aging of 80 years old, whereas 60 years old people reveal a biological aging of 60 years old. The key issue is to understand why the biological aging of the skeletal muscle is so different between people.
Previous sarcopenia studies in Humans did not really focus on chronological aging, they were all based on a comparison between young and old people. No study considered inter-individual modifications (biological aging) in sarcopenia. Furthermore, few studies were associated in the same study to "omic", histological, and epigenetic data, to obtain integrated point of view of Human Sarcopenia.
In this study, mechanisms involved in biological aging of the skeletal muscle in aging people (same chronological age) will be specified.
- Conditions
- HEALTHY
- Being tested
- Proof cohort : muscular assessment
- Keywords
- sarcopenia, elderly, muscle biopsy
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proof cohort : muscular assessmentOther
Clinical examination, blood appraisal, urinary collection, MVC, checking muscle functional skills and muscular biopsy will be performed.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Proof cohort : muscular assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study start18 Feb 2016
- Primary completion20 Jan 2017
- Study completion23 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HEALTHYStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole Nationale Superieure Lyon, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Region Rhone Alpes
- Responsible party
- Sponsor
- Investigators
- FEASSON Léonard, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675192
- Sponsor's protocol ID
- 1508145
- Other IDs
- 2015-A01484-45
- Acronym
- BioAge
- Status last verified
- May 2021
- First submitted
- 25 Jan 2016
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17898520
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Aging of Skeletal Muscles in Humans, a Monocentric, Prospective Study
- ClinicalTrials.gov ID
- NCT02675192
- Acronym / sponsor ID
- BioAge / 1508145
- Conditions
- HEALTHY
- Keywords
- sarcopenia, elderly, muscle biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ecole Nationale Superieure Lyon, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Region Rhone Alpes
- Study start
- 18 Feb 2016 (actual)
- Primary completion
- 20 Jan 2017 (actual)
- Study completion
- 23 May 2017 (actual)
- First posted
- 5 Feb 2016 (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.
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.
Detailed description
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. Some elderly (60 years old) reveal a biological aging of 80 years old, whereas 60 years old people reveal a biological aging of 60 years old. The key issue is to understand why the biological aging of the skeletal muscle is so different between people.
Previous sarcopenia studies in Humans did not really focus on chronological aging, they were all based on a comparison between young and old people. No study considered inter-individual modifications (biological aging) in sarcopenia. Furthermore, few studies were associated in the same study to "omic", histological, and epigenetic data, to obtain integrated point of view of Human Sarcopenia.
In this study, mechanisms involved in biological aging of the skeletal muscle in aging people (same chronological age) will be specified.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proof cohort : muscular assessment | – | Other: 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 |
Who may qualify
- Ages
- 80 to 83 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients are recruited in the Proof cohort (Barthélemy et al., 2007).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Anti coagulative treatment
- Severe obesity (>35)
- All chronic pathology requiring a treatment
- Severe renal insufficiency (discovery less than 6 months)
- Abnormal coagulation appraisal
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 |
|---|---|---|
| Proof cohort : muscular assessmentClinical examination, blood appraisal, urinary collection, MVC, checking muscle functional skills and muscular biopsy will be performed. | Other | Proof cohort : muscular assessment |
Primary outcome
The area of type IIA fibers called vastus lateralis.
Time frame: Day 15
The primary endpoint is the cross sectional area (measured in µm2) of type IIA fibers from the vastus lateralis muscle biopsies.
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 17 Nov 2021.
- Background: PubMed 17898520Barthelemy 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.
- Individual participant dataSharing planned: No
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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.
FEASSON Léonard, MD principal investigator
Centre Hospitalier Universitaire 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 HEALTHY, 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 5 inclusion and 9 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 17 Nov 2021. 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?
The area of type IIA fibers called vastus lateralis. (time frame: Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02675192, which also lists 1 linked publication.
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 17 Nov 2021.