Age-related Degenerated DiseaseCompalimageNCT00862615
Relationships Between Quality of Ageing and Age-related Degenerated Disease (Compalimage)
A study testing Measurement of muscle protein synthesis using stable isotopes and muscle biopsies. in people with Age-related Degenerated Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
This project aims to assess the impact of chronic micro-inflammation on age-related loss of muscle (sarcopenia) and bone (osteopenia). The hypothesis is that chronic micro-inflammation and oxidative stress, which prevalence increases during ageing, may participate in the pathogenesis of both sarcopenia and osteopenia. Read more about this study
- Who is it for?
- Ages 65 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Age-related Degenerated Disease
- What is being tested?
- Measurement of muscle protein synthesis using stable isotopes and muscle biopsies.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Jan 2011
- 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 65 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male
- Body mass index 21 BMI 30 kg/m2
- Affiliated to National Health Insurance
- Subject giving his written informed consent
- Subject considered as normal after clinical examination and medical questionnaire.
Who cannot join
- Positive serologies to HIV or HCV, determined on blood samples
- Previous medical and/or surgery judged by the investigator as incompatible with this study
- Chronic pathologies : Diabetes, cardiovascular diseases, cancer, chronic inflammation diseases, renal, pulmonary impairments Reported xylocaïne allergy
- Osteoporosis
- Prostate hypertrophy
- Glaucoma
Show all 12Show fewer
- Heavy consumer of alcohol
- Practising intensive physical exercise
- Being under someone's supervision
- Refusal to be registered on the National Volunteers Data file
- Dietary habits unreliable to controlled food intake
- Being in exclusion on the National Volunteers Data file
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick Lacarin, 04.73.75.11.95, placarin@chu-clermont-ferrand.fr
About this study
Official title: Chronic Micro-inflammation and Bone and Muscular Status in Elderly
This project aims to assess the impact of chronic micro-inflammation on age-related loss of muscle (sarcopenia) and bone (osteopenia). The hypothesis is that chronic micro-inflammation and oxidative stress, which prevalence increases during ageing, may participate in the pathogenesis of both sarcopenia and osteopenia.
Read the detailed description
In order to explore the effect of a moderate chronic inflammation on skeletal muscle function and protein metabolism and on bone status, two groups of 16 subjects each will be selected according to their inflammatory status ie non-inflamed versus micro-inflamed. The volunteers will be sampled twice at week 0 and week 6 in order to quantify plasma concentration of C reactive protein (CRP) using the ultra sensitive assay. The subjects exhibiting CRP lower than 1 mg/l twice will be included in the non-inflamed group and the subjects exhibiting CRP higher than 3 and lower than 15 mg/l will be included in the micro-inflamed group.
During the two weeks before the metabolic studies dietary intakes, DEXA, muscle function, VO2 max and biomarkers of bone remodelling will be assessed. Volunteers will then be submitted to a diet controlled for its protein content, for 4 days (1 g protein/kg/day and 30 kcal/kg/day) before metabolic investigations. One day before, urine will be collected for metabolomics. On the day of metabolic investigations, after an overnight fast, blood samples will be collected for albumin, fibrinogen, inflammatory cytokine and adipokine determination. Then, the subjects will be perfused with L-[1-13C] leucine for 8 hours (post absorptive sate then post prandial satte) during which expired gas and blood samples will be taken, as well as 2 muscle biopsies. Isotopic enrichments in expired gas, in plasma cetoiscaproate and in free or protein-bound leucine in muscle will be measured to determine proteolysis and proteosynthesis rate of muscle proteins.
- Conditions
- Age-related Degenerated Disease
- Being tested
- Measurement of muscle protein synthesis using stable isotopes and muscle biopsies.
- Keywords
- Ageing, Inflammation, Muscle protein synthesis, Osteopenia, Sarcopenia
- Medical subject headings
- Inflammation, Bone Diseases, Metabolic, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of muscle protein synthesis using stable isotopes and muscle biopsies.Other
Measurement of muscle protein synthesis using stable isotopes and muscle biopsies.
Isotopes are :
(13C)bicarbonate (0.09 mg/kg fat-free mass) and L(1-13C)leucine (1.3 mg/kg fat-free mass) (intravenous way) L-(5,5,5 2H3) leucine(0.09 µmoles/(kg de fat-free mass.min) (oral way)
What is being measured
The primary outcome is the main question the study is designed to answer.
Isotopic enrichments in expired gas, in plasma cetoisocaproate and in free or protein-bound leucine in muscle will be measured to determine proteolysis and proteosynthesis rate of muscle proteins.
Measured: at week 0 and week 6
Secondary outcomes (1)
Splanchnic extraction of amino acids, bone metabolism, muscular strength, global metabolism and quality of life.
Measured: at week 0 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Degenerated DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Institut National de la Santé Et de la Recherche Médicale, France
- Investigators
- Noël CANO, Principal investigator, University Hospital, Clermont-FerrandDominique Dardevet, Study director, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862615
- Sponsor's protocol ID
- CHU-0048
- Other IDs
- IDRCB 2008-A00593-52, AU750
- Acronym
- Compalimage
- Status last verified
- Sep 2010
- First submitted
- 12 Mar 2009
- Last updated
- 29 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Micro-inflammation and Bone and Muscular Status in Elderly
- ClinicalTrials.gov ID
- NCT00862615
- Acronym / sponsor ID
- Compalimage / CHU-0048
- Conditions
- Age-related Degenerated Disease
- Keywords
- Ageing, Inflammation, Muscle protein synthesis, Osteopenia, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Jan 2009
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 17 Mar 2009 (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 project aims to assess the impact of chronic micro-inflammation on age-related loss of muscle (sarcopenia) and bone (osteopenia). The hypothesis is that chronic micro-inflammation and oxidative stress, which prevalence increases during ageing, may participate in the pathogenesis of both sarcopenia and osteopenia.
Detailed description
In order to explore the effect of a moderate chronic inflammation on skeletal muscle function and protein metabolism and on bone status, two groups of 16 subjects each will be selected according to their inflammatory status ie non-inflamed versus micro-inflamed. The volunteers will be sampled twice at week 0 and week 6 in order to quantify plasma concentration of C reactive protein (CRP) using the ultra sensitive assay. The subjects exhibiting CRP lower than 1 mg/l twice will be included in the non-inflamed group and the subjects exhibiting CRP higher than 3 and lower than 15 mg/l will be included in the micro-inflamed group.
During the two weeks before the metabolic studies dietary intakes, DEXA, muscle function, VO2 max and biomarkers of bone remodelling will be assessed. Volunteers will then be submitted to a diet controlled for its protein content, for 4 days (1 g protein/kg/day and 30 kcal/kg/day) before metabolic investigations. One day before, urine will be collected for metabolomics. On the day of metabolic investigations, after an overnight fast, blood samples will be collected for albumin, fibrinogen, inflammatory cytokine and adipokine determination. Then, the subjects will be perfused with L-[1-13C] leucine for 8 hours (post absorptive sate then post prandial satte) during which expired gas and blood samples will be taken, as well as 2 muscle biopsies. Isotopic enrichments in expired gas, in plasma cetoiscaproate and in free or protein-bound leucine in muscle will be measured to determine proteolysis and proteosynthesis rate of muscle proteins.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Male
- Body mass index 21 BMI 30 kg/m2
- Affiliated to National Health Insurance
- Subject giving his written informed consent
- Subject considered as normal after clinical examination and medical questionnaire.
Key exclusion criteria (12 listed)
- Positive serologies to HIV or HCV, determined on blood samples
- Previous medical and/or surgery judged by the investigator as incompatible with this study
- Chronic pathologies : Diabetes, cardiovascular diseases, cancer, chronic inflammation diseases, renal, pulmonary impairments Reported xylocaïne allergy
- Osteoporosis
- Prostate hypertrophy
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 |
|---|---|---|
| Measurement of muscle protein synthesis using stable isotopes and muscle biopsies.Measurement of muscle protein synthesis using stable isotopes and muscle biopsies. Isotopes are : (13C)bicarbonate (0.09 mg/kg fat-free mass) and L(1-13C)leucine (1.3 mg/kg fat-free mass) (intravenous way) L-(5,5,5 2H3) leucine(0.09 µmoles/(kg de fat-free mass.min) (oral way) | Other | – |
Primary outcome
Isotopic enrichments in expired gas, in plasma cetoisocaproate and in free or protein-bound leucine in muscle will be measured to determine proteolysis and proteosynthesis rate of muscle proteins.
Time frame: at week 0 and week 6
1 secondary outcome
Splanchnic extraction of amino acids, bone metabolism, muscular strength, global metabolism and quality of life.
Time frame: at week 0 and week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2010.
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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.
Noël CANO principal investigator
University Hospital, Clermont-Ferrand
Dominique Dardevet study director
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of muscle protein synthesis using stable isotopes and muscle biopsies. in people with Age-related Degenerated Disease, run by University Hospital, Clermont-Ferrand 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 12 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: status not confirmed, as of the sponsor's last update on 29 Sep 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Lacarin (04.73.75.11.95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isotopic enrichments in expired gas, in plasma cetoisocaproate and in free or protein-bound leucine in muscle will be measured to determine proteolysis and proteosynthesis rate of muscle proteins. (time frame: at week 0 and week 6). 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 29 Sep 2010.