Estimation of Muscle Mass in Older Adults Using Deuterated Creatine

NCT02062086 | Terminated

• 2 other identifiers: RC31/13/69112013-A01339-36
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

Sarcopenia; Mass muscle; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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.

  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

  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

  Evaluate the feasibility of developing a blood based assay using deuterium labeled creatine dilution for the estimation of muscle mass.

Study Arms (2)

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.

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.

Dietary Supplement: deuterated creatine 30 mg

Interventions

deuterated creatine 30 mg DIETARY_SUPPLEMENT

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

Population 1; Population 2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

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

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Gabor Abellan Van Kan, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 13, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

FR (1)