Back to resultsEstimation of Muscle Mass in Older Adults Using Deuterated Creatine (MM-DC)
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
deuterated creatine 30 mg
Sponsored by
About this trial
This is an interventional prevention trial for Sarcopenia focused on measuring Sarcopenia, Mass muscle, Quality of life
Eligibility Criteria
Inclusion criteria
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
- 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
Exclusion criteria
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.
- 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
Sites / Locations
- Gerontopôle - CHU La Grave Casselardit - Serv. de Médecine Interne & de Gérontologie Clinique - 170 av de Casselardit - TSA 40031
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Population 1
Population 2
Arm Description
(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.
(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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
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
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.
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.
Full Information
NCT ID
NCT02062086
First Posted
February 6, 2014
Last Updated
August 24, 2020
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02062086
Brief Title
Estimation of Muscle Mass in Older Adults Using Deuterated Creatine
Acronym
MM-DC
Official Title
Estimation of Muscle Mass in Older Adults Using Deuterated Creatine
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Sarcopenia, Mass muscle, Quality of life
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Population 1
Arm Type
Other
Arm Description
(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.
Arm Title
Population 2
Arm Type
Other
Arm Description
(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.
Intervention Type
Dietary Supplement
Intervention Name(s)
deuterated creatine 30 mg
Intervention Description
Study participants will take a single oral dose of deuterated creatine 30 mg in capsule form
Primary Outcome Measure Information:
Title
Muscle mass quantity
Description
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.
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
Secondary Outcome Measure Information:
Title
Repeatability of muscle mass estimates
Description
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.
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
Title
Creatine dilution of the deuterium labeled
Description
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.
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
Title
Association of muscle mass with measures of lower extremity function, muscle strength and physical activity.
Description
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
Time Frame
Examine the association of muscle mass with measures of lower extremity function, muscle strength and physical activity.
Title
Association of measures of muscle mass, muscle strength and levels of physical activity with quality of life assessments
Description
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
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.
Title
Feasibility of the method
Description
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.
Time Frame
Evaluate the feasibility of developing a blood based assay using deuterium labeled creatine dilution for the estimation of muscle mass.
Title
Correlation between muscle function and muscle mass
Description
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.
Time Frame
Assess if there exists a correlation between muscle function and muscle mass estimated by D3-Creatine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
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
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
Exclusion criteria
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabor Abellan Van Kan, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gerontopôle - CHU La Grave Casselardit - Serv. de Médecine Interne & de Gérontologie Clinique - 170 av de Casselardit - TSA 40031
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
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Estimation of Muscle Mass in Older Adults Using Deuterated Creatine
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