SarcopeniaMM-DCNCT02062086
Estimation of Muscle Mass in Older Adults Using Deuterated Creatine
A study testing deuterated creatine 30 mg in people with Sarcopenia, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Current methods for the quantification of muscle mass are indirect, lack precision, and often rely on expensive equipment that only provides limited (indirect) data on whole body muscle mass. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- deuterated creatine 30 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Dec 2018
- 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
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Population 1: Community-dwelling older adults:
- Community-dwelling at the time of the assessment
- Ambulatory without human assistance at the time of the assessment
- ADL (activity of daily living)equal to 5 or more at the time of the assessment
- Population 2: Older adults recovering after hip fracture surgery:
- Age ≥ 65 at the time of the fracture
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- Minimal trauma hip fracture (Diagnosis of closed fracture of the proximal femur and no history of a fall from height higher than standing height (e.g. fall from a roof or a ladder); no history of a high impact fracture (e.g. car accident, skiing)
- Unilateral hip fracture
- Surgical repair of hip fracture
- Surgical intervention taking place within 7 days since admission to the acute care unit.
- Living in the community at the time of the fracture
- Anticipated discharge back to the community
- Ambulatory without human assistance prior to the fracture
- ADL (activity of daily living) equal to 5 or more prior to the fracture
Who cannot join
- Population 1:Community-dwelling elderly:
- Diagnosis of dementia
- Presence of cognitive impairment (assessed during clinical follow-up using standardized cognitive tools such as MMSE (Mini Mental Status Examination) or MOCA (Montreal Cognitive Assessment), during pre-screening period).
- Inability to provide informed consent
- Presence of severe or uncontrolled neurodegenerative disease like Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis
- Presence of an underlying muscle disease other than age-associated muscle waste or disuse atrophy.
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- History of stroke with residual hemiplegia
- Diagnosis of a severe medical or psychiatric condition making the participant unlikely to understand or comply with study protocol.
- Diagnosis of malignancy done in the 18 months prior the baseline visit.
- Severe renal failure
- Population 2: Older adults recovering from hip fracture:
- Pathological hip fracture
- Diagnosis of dementia
- Presence of cognitive impairment (assessed during clinical follow-up using standardized cognitive tools such as MMSE (Mini Mental Status Examination) or MOCA (Montreal Cognitive Assessment), during prescreening period).
- Peri-operative delirium persisting after day 5 of post-operative period.
- Inability to provide informed consent
- Presence of severe or uncontrolled neurodegenerative disease like Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis
- Presence of an underlying muscle disease other than age-associated muscle waste or disuse atrophy.
- History of stroke with residual hemiplegia
- Diagnosis of a severe medical or psychiatric condition making the participant unlikely to understand or comply with study protocol.
- Diagnosis of malignancy done in the 18 months prior the baseline visit.
- Severe renal failure
Trial locations and contacts
1 site in 1 country.
France1 site
Gerontopôle - CHU La Grave Casselardit - Serv. de Médecine Interne & de Gérontologie Clinique - 170 av de Casselardit - TSA 40031
Toulouse, 31059
About this study
Current methods for the quantification of muscle mass are indirect, lack precision, and often rely on expensive equipment that only provides limited (indirect) data on whole body muscle mass. Dual energy X ray absorptiometry has emerged as a potential precise measure of lean mass, easy to use in clinical practice and research. However, it assesses an indirect measurement of total-body skeletal muscle mass and its clinical use for determination of changes in muscle mass may be very limited due to instrumentation availability, particularly in field studies, and cost. Moreover, these methods provide estimates of fat free mass that is not skeletal muscle specific, and are influenced by changes in regional or total body water content.
GlaxoSmithKline (GSK) has developed a novel technique using deuterium labeled creatine dilution for the estimation of muscle mass and has begun clinical evaluation of this muscle-measure in healthy young and older adults.
Read the detailed description
Mobility disability in acute and chronic settings like the Frailty day Hospital or the rehabilitation units make it difficult to assess muscle mass other than the availability of imaging techniques. Often it is impossible to assess muscle mass due to accessibility and cost of actual techniques. Deuterium labeled creatine (contained in capsules to be swallowed) is an easy procedure to assess muscle mass that could avoid the existing difficulties when using imaging techniques. Capsules containing the deuterium labeled creatine will be administered to participants who will autonomously take them. The subsequent assessment of urinary deuterium dilution will provide the estimate of skeletal muscle mass of the individual.
Primary outcome: Assess muscle mass quantity in older adults using the method of deuterium labeled creatine versus the DXA (Dual Energy X-ray Absorptiometry) total lean mass assessment.
- Conditions
- Sarcopenia
- Being tested
- deuterated creatine 30 mg
- Keywords
- Sarcopenia, Mass muscle, Quality of life
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deuterated creatine 30 mgDietary supplement
Study participants will take a single oral dose of deuterated creatine 30 mg in capsule form
| Study group | Role | What they receive |
|---|---|---|
| Population 1 | Other | (Community-dwelling older adults) will participate in the study for approximately 65 days.
Population 1 will absorb deuterated creatine 30 mg, a non-radioactive, stable isotope of creatine, for the estimation of muscle mass in humans.
The estimation of muscle mass will be made on 2 separate occasions in the community-dwelling elderly population in order to assess reproducibility of the method when tested approximately 60 days apart. Receives: Dietary Supplement: deuterated creatine 30 mg |
| Population 2 | Other | (Hip-fracture patients) will participate in the study for approximately 35 days during their in-hospital period, followed by 30 during their post-discharge period, so for a total period of at least 65 days.
Population 2 will absorb deuterated creatine 30 mg, a non-radioactive, stable isotope of creatine, for the estimation of muscle mass in humans.
In the hip fracture population, estimation of muscle mass by the D3 creatine method will be performed on up to 3 separate occasions to assess whether the method is sensitive enough to detect decreases in muscle mass that may occur during the recovery period after hip fracture. Receives: Dietary Supplement: deuterated creatine 30 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass quantity
Study participants will take a single oral dose of deuterated creatine 30 mg in capsule form. Muscle mass quantity will be assessed using D3-creatine technique.
Measured: Assess muscle mass quantity in older adults using the method of deuterium labeled creatine versus the DXA total lean mass assessment. Modification of the muscle mass quantity between Day 4 and Day 64
Secondary outcomes (6)
Repeatability of muscle mass estimates
The estimation of muscle mass will be made on 2 separate occasions in the community-dwelling elderly population in order to assess reproducibility of the method when tested approximately 60 days apart.
Measured: Evaluate the repeatability of muscle mass estimates from deuterium labeled creatine dilution method in community dwelling elderly subjects who meet specific "frailty" criteria. The repeatability will be assessed comparing day 4 and day 64
Creatine dilution of the deuterium labeled
Estimation of muscle mass by the D3 creatine method will be performed on up to 3 separate occasions to assess whether the method is sensitive enough to detect decreases in muscle mass that may occur during the recovery period after hip fracture.
Measured: Evaluate the deuterium labeled creatine dilution for sensitivity to changes in muscle mass in the hip fracture population during the period after fracture when muscle mass is expected to decline. It will be assessed comparing day 4, day 34 and day 64
Association of muscle mass with measures of lower extremity function, muscle strength and physical activity.
Lower extremity function will be assessed longitudinally in both cohorts using:
Short Physical Performance Battery (SPPB) and The six minute walk test (6-MWT)
To measure the physical activity:
Self-reported physical activity - The Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ) Accelerometer measurement
To measure muscle strength:
Leg extension strength Handgrip strength
Measured: Examine the association of muscle mass with measures of lower extremity function, muscle strength and physical activity.
Association of measures of muscle mass, muscle strength and levels of physical activity with quality of life assessments
- Quality of life assessed by EuroQol.
- Sarcopenia Patient Reported Outcome Assessment
- Self-Reported Function Using these questionnaires and measurements, we will try to find out the link between muscle mass, muscle strength, level of physical activity and quality of life
Measured: Examine the association of measures of muscle mass, muscle strength and levels of physical activity with quality of life assessments and patient reported outcomes.
Feasibility of the method
The current method is based on analyses from urine sampling; however, plasma samples will also be drawn in this study to evaluate the feasibility of developing a blood based assay. Blood sampling is much easier than urine assessments, so that in future studies blood sampling would be the assessment of choice if the dosing proofs to be feasible.
Measured: Evaluate the feasibility of developing a blood based assay using deuterium labeled creatine dilution for the estimation of muscle mass.
Correlation between muscle function and muscle mass
The study will also explore if not only measures of muscle mass, but also if muscle function are correlated with urine and blood sampling of D3 creatine.
Measured: Assess if there exists a correlation between muscle function and muscle mass estimated by D3-Creatine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabor Abellan Van Kan, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062086
- Sponsor's protocol ID
- RC31/13/6911
- Other IDs
- 2013-A01339-36
- Acronym
- MM-DC
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2014
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Muscle Mass in Older Adults Using Deuterated Creatine
- ClinicalTrials.gov ID
- NCT02062086
- Acronym / sponsor ID
- MM-DC / RC31/13/6911
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Mass muscle, Quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 13 Feb 2014 (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.
Current methods for the quantification of muscle mass are indirect, lack precision, and often rely on expensive equipment that only provides limited (indirect) data on whole body muscle mass. Dual energy X ray absorptiometry has emerged as a potential precise measure of lean mass, easy to use in clinical practice and research. However, it assesses an indirect measurement of total-body skeletal muscle mass and its clinical use for determination of changes in muscle mass may be very limited due to instrumentation availability, particularly in field studies, and cost. Moreover, these methods provide estimates of fat free mass that is not skeletal muscle specific, and are influenced by changes in regional or total body water content.
GlaxoSmithKline (GSK) has developed a novel technique using deuterium labeled creatine dilution for the estimation of muscle mass and has begun clinical evaluation of this muscle-measure in healthy young and older adults.
Detailed description
Mobility disability in acute and chronic settings like the Frailty day Hospital or the rehabilitation units make it difficult to assess muscle mass other than the availability of imaging techniques. Often it is impossible to assess muscle mass due to accessibility and cost of actual techniques. Deuterium labeled creatine (contained in capsules to be swallowed) is an easy procedure to assess muscle mass that could avoid the existing difficulties when using imaging techniques. Capsules containing the deuterium labeled creatine will be administered to participants who will autonomously take them. The subsequent assessment of urinary deuterium dilution will provide the estimate of skeletal muscle mass of the individual.
Primary outcome: Assess muscle mass quantity in older adults using the method of deuterium labeled creatine versus the DXA (Dual Energy X-ray Absorptiometry) total lean mass assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population 1 | Other | Dietary Supplement: deuterated creatine 30 mg(Community-dwelling older adults) will participate in the study for approximately 65 days. Population 1 will absorb deuterated creatine 30 mg, a non-radioactive, stable isotope of creatine, for the estimation of muscle mass in humans. The estimation of muscle mass will be made on 2 separate occasions in the community-dwelling elderly population in order to assess reproducibility of the method when tested approximately 60 days apart. |
| Population 2 | Other | Dietary Supplement: deuterated creatine 30 mg(Hip-fracture patients) will participate in the study for approximately 35 days during their in-hospital period, followed by 30 during their post-discharge period, so for a total period of at least 65 days. Population 2 will absorb deuterated creatine 30 mg, a non-radioactive, stable isotope of creatine, for the estimation of muscle mass in humans. In the hip fracture population, estimation of muscle mass by the D3 creatine method will be performed on up to 3 separate occasions to assess whether the method is sensitive enough to detect decreases in muscle mass that may occur during the recovery period after hip fracture. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- Community-dwelling at the time of the assessment
- Ambulatory without human assistance at the time of the assessment
- ADL (activity of daily living)equal to 5 or more at the time of the assessment
- Age ≥ 65 at the time of the fracture
- Minimal trauma hip fracture (Diagnosis of closed fracture of the proximal femur and no history of a fall from height higher than standing height (e.g. fall from a roof or a ladder); no history of a high impact fracture (e.g. car accident, skiing)
Key exclusion criteria (22 listed)
- Diagnosis of dementia
- Presence of cognitive impairment (assessed during clinical follow-up using standardized cognitive tools such as MMSE (Mini Mental Status Examination) or MOCA (Montreal Cognitive Assessment), during pre-screening period).
- Inability to provide informed consent
- Presence of severe or uncontrolled neurodegenerative disease like Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis
- Presence of an underlying muscle disease other than age-associated muscle waste or disuse atrophy.
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 |
|---|---|---|
| deuterated creatine 30 mgStudy participants will take a single oral dose of deuterated creatine 30 mg in capsule form | Dietary supplement | Population 1, Population 2 |
Primary outcome
Muscle mass quantity
Time frame: Assess muscle mass quantity in older adults using the method of deuterium labeled creatine versus the DXA total lean mass assessment. Modification of the muscle mass quantity between Day 4 and Day 64
Study participants will take a single oral dose of deuterated creatine 30 mg in capsule form. Muscle mass quantity will be assessed using D3-creatine technique.
6 secondary outcomes
Repeatability of muscle mass estimates
Time frame: Evaluate the repeatability of muscle mass estimates from deuterium labeled creatine dilution method in community dwelling elderly subjects who meet specific "frailty" criteria. The repeatability will be assessed comparing day 4 and day 64
Creatine dilution of the deuterium labeled
Time frame: Evaluate the deuterium labeled creatine dilution for sensitivity to changes in muscle mass in the hip fracture population during the period after fracture when muscle mass is expected to decline. It will be assessed comparing day 4, day 34 and day 64
Association of muscle mass with measures of lower extremity function, muscle strength and physical activity.
Time frame: Examine the association of muscle mass with measures of lower extremity function, muscle strength and physical activity.
Association of measures of muscle mass, muscle strength and levels of physical activity with quality of life assessments
Time frame: Examine the association of measures of muscle mass, muscle strength and levels of physical activity with quality of life assessments and patient reported outcomes.
Feasibility of the method
Time frame: Evaluate the feasibility of developing a blood based assay using deuterium labeled creatine dilution for the estimation of muscle mass.
Correlation between muscle function and muscle mass
Time frame: Assess if there exists a correlation between muscle function and muscle mass estimated by D3-Creatine
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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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.
Gabor Abellan Van Kan, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deuterated creatine 30 mg in people with Sarcopenia, run by University Hospital, Toulouse 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 14 inclusion and 22 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: stopped early, as of the sponsor's last update on 6 May 2026. 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 was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
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?
Muscle mass quantity (time frame: Assess muscle mass quantity in older adults using the method of deuterium labeled creatine versus the DXA total lean mass assessment. Modification of the muscle mass quantity between Day 4 and Day 64). 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 6 May 2026.