AgingSirt6NCT01567176
Circulating SIRT6 Expression, Effect on Aging Quality
A study testing Blood sample in people with Aging, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
This study follows the results of the COMPALICLAMP study (NCT00951392) where the investigators showed a differential expression of sirtuins protein isoforms, Sirt6, in muscle depending on the quality of aging. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2012to Sep 2012
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers from the SUVIMAX 2 aging cohort
- Men and women
- Older than 60
- Subject with a global aging quality score of 1 or 3 in the SU.VI.MAX. 2 study
- Covered by Health Insurance System
Who cannot join
- Subject not in compliance with the recommendation of French National Law
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre de recherche en nutrition humaine Rhone-Alpes
Pierre-Bénite, 69310
Centre de Recherche en Nutrition Humaine
Pierre-Bénite, 69310
About this study
Official title: Circulating Expression Measurement of a Sirtuin Protein Isoform, Sirt6, as an Early Marker of Aging Quality
This study follows the results of the COMPALICLAMP study (NCT00951392) where the investigators showed a differential expression of sirtuins protein isoforms, Sirt6, in muscle depending on the quality of aging. The investigators seek to confirm this difference in expression level of circulating leukocytes on a larger sample.
- Conditions
- Aging
- Being tested
- Blood sample
- Keywords
- Sirtuins, Aging, Metabolic disease
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
It is a single cross sectional study. All outcome measures will be taken during the investigation with physical examination, questionnaire and a blood sample
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Not described Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sirt6 expression in circulating leukocytes based on the aging quality
analysis by quantitative RT-PCR method
Measured: participants will be followed for the duration of the visit, an expected average of 1 day
Secondary outcomes (4)
hand and forearm muscular strength measurement
Hand Grip strength test
Measured: participants will be followed for the duration of the visit, an expected average of 1 day
Physical examination and anthropometric measurement
Measurement of the weight, height, waist, hips, blood pressure, pulse.
Measured: participants will be followed for the duration of the visit, an expected average of 1 day
Cognitive assessment
MMSE (Mini Mental State Examination), Five-word test, clock drawing
Measured: participants will be followed for the duration of the visit, an expected average of 1 day
Physical Activity questionnaire
MAQ (Modifiable Activity Questionnaire)
Measured: participants will be followed for the duration of the visit, an expected average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2012
- Study completionSep 2012
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 AgingStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine LAVILLE, Pr, Principal investigator, Centre de recherche en nutrition humaine Rhone-Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567176
- Sponsor's protocol ID
- 2011.674
- Acronym
- Sirt6
- Status last verified
- Feb 2012
- First submitted
- 8 Mar 2012
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Betry C, Meugnier E, Pflieger M, Grenet G, Hercberg S, Galan P, Kesse-Guyot E, Vidal H, Laville M. High expression of CPT1b in skeletal muscle in metabolically healthy older subjects. Diabetes Metab. 2019 Apr;45(2):152-159. doi: 10.1016/j.diabet.2018.01.018. Epub 2018 Feb 12.
PubMed 29657112
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Expression Measurement of a Sirtuin Protein Isoform, Sirt6, as an Early Marker of Aging Quality
- ClinicalTrials.gov ID
- NCT01567176
- Acronym / sponsor ID
- Sirt6 / 2011.674
- Conditions
- Aging
- Keywords
- Sirtuins, Aging, Metabolic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Mar 2012 (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.
This study follows the results of the COMPALICLAMP study (NCT00951392) where the investigators showed a differential expression of sirtuins protein isoforms, Sirt6, in muscle depending on the quality of aging. The investigators seek to confirm this difference in expression level of circulating leukocytes on a larger sample.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Biological: Blood sample |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteers from the SUVIMAX 2 aging cohort
- Men and women
- Older than 60
- Subject with a global aging quality score of 1 or 3 in the SU.VI.MAX. 2 study
- Covered by Health Insurance System
Key exclusion criteria (1 listed)
- Subject not in compliance with the recommendation of French National Law
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 |
|---|---|---|
| Blood sampleIt is a single cross sectional study. All outcome measures will be taken during the investigation with physical examination, questionnaire and a blood sample | Biological | Single Arm |
Primary outcome
Sirt6 expression in circulating leukocytes based on the aging quality
Time frame: participants will be followed for the duration of the visit, an expected average of 1 day
analysis by quantitative RT-PCR method
4 secondary outcomes
hand and forearm muscular strength measurement
Time frame: participants will be followed for the duration of the visit, an expected average of 1 day
Physical examination and anthropometric measurement
Time frame: participants will be followed for the duration of the visit, an expected average of 1 day
Cognitive assessment
Time frame: participants will be followed for the duration of the visit, an expected average of 1 day
Physical Activity questionnaire
Time frame: participants will be followed for the duration of the visit, an expected average of 1 day
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 28 May 2019.
- Results publication: PubMed 29657112Betry C, Meugnier E, Pflieger M, Grenet G, Hercberg S, Galan P, Kesse-Guyot E, Vidal H, Laville M. High expression of CPT1b in skeletal muscle in metabolically healthy older subjects. Diabetes Metab. 2019 Apr;45(2):152-159. doi: 10.1016/j.diabet.2018.01.018. Epub 2018 Feb 12.
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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.
Martine LAVILLE, Pr principal investigator
Centre de recherche en nutrition humaine Rhone-Alpes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Aging, run by Hospices Civils de Lyon at 2 sites 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 1 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 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Sirt6 expression in circulating leukocytes based on the aging quality (time frame: participants will be followed for the duration of the visit, an expected average of 1 day). 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 NCT01567176, 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 28 May 2019.