Estimation of Muscle Mass in Older Adults Using Deuterated Creatine

NCT ID: NCT02062086

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2018-12-31

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.

Conditions

Sarcopenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Population 1

(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.

Group Type: OTHER

deuterated creatine 30 mg

Intervention Type: DIETARY_SUPPLEMENT

Study participants will take a single oral dose of deuterated creatine 30 mg in capsule form

Population 2

(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.

Group Type: OTHER

deuterated creatine 30 mg

Intervention Type: DIETARY_SUPPLEMENT

Study participants will take a single oral dose of deuterated creatine 30 mg in capsule form

Interventions

deuterated creatine 30 mg

Study participants will take a single oral dose of deuterated creatine 30 mg in capsule form

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabor Abellan Van Kan, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Gerontopôle - CHU La Grave Casselardit - Serv. de Médecine Interne & de Gérontologie Clinique - 170 av de Casselardit - TSA 40031

Toulouse, , France

Countries

France

Other Identifiers

2013-A01339-36

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/13/6911

Identifier Type: -

Identifier Source: org_study_id