TerminatedNot Applicable

Estimation of Muscle Mass in Older Adults Using Deuterated Creatine

Stopped: insufficient recruitment

France33 participantsStarted 2014-06

Plain-language 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.

Who can participate

Age range65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

What they're measuring

Muscle mass quantity

Timeframe: 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

Trial details

NCT IDNCT02062086

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12