Clinical Evaluation, Biomarkers and Metabolomics of Sarcopenia in Frail Older Adults at Ambulatory Clinics (EC0991002-E)

Sarcopenia related mobility dysfunction was a preventable presentation in transitional variation of frailty. However, the definition, associated risk factors, clinical course and outcome of sarcopenia in Taiwanese older adults are still under-clarified and need for further study.

Study Overview

• Status: Unknown
• Conditions: Frailty; Sarcopenia

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects One thousand Taiwanese subjects aged 20-40 will be recruited equally divided in both genders. Exclusion criteria includes (1) morbid obesity (BMI over 35) ; (2) long term use of body composition modified medications, like steroid, medications for endocrine diseases (hyperthyroidism, diabetes) and autoimmune diseases; (3) energy consumption diseases, such as cancer, organ failure; (4) pregnant women.

Patient enrollment The research subjects will be culled from outpatients aged over 65 at NTUH.

Description

Inclusion Criteria:

• functional decline in recent one year
• cognitive impairment
• depressive symptom
• mobility impairment
• fall in recent one year
• eating or feeding problems
• weight loss
• co-morbid conditions≧5
• tracking by different physician ≧3 in recent half year
• poly-pharmacy≧8 in recent 3 months
• hospitalization ≧1 in recent one year
• emergency visits≧2 in recent one year
• aged ≧ 80.

Exclusion Criteria:

• non-ambulatory (bed-ridden) patients
• long-term residents at nursing homes
• patients with a life expectancy shorter than six months
• impairment in vision, hearing, or communicative ability, making convenience of clinical evaluation during the study period impossible.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
health subjects; outpatients aged over 65; The research subjects will be culled from outpatients aged over 65 at NTUH; 1000 Taiwanese subjects aged 20-40 equally divided in both genders will be recruited in order to establish the norm of Taiwanese's skeletal muscle index.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Domestic operation tool of sarcopenia for older adults	Young health adults are recruited for measurement of body composition using bio impedance analysis in order to establish the norm of skeletal muscle index	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in body composition during aging	Using anthropometric measurements, and bio impedance analysis, the change in body composition are measured in the recruited older adults	up to 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare metabolomics profiles in sarcopenic older adults and non-sarcopenic older adults	Using the blood specimen, the metabolomics platform are set up to explore the new bio markers of sarcopenia in older adults	up to 2 years
The prognosis of sarcopenia in the older adults	The adverse health outcomes, including hospitalization, emergency visits, or fall events, are recorded every 3 months in order to examine the prognosis of sarcopenia in the elderly	up to 2 years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Health Research Institutes, Taiwan; National Taiwan University
• Investigators: Principal Investigator: Ching-Yu Chen, MD, National Tiwan University, College of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: August 30, 2011
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (Estimate): February 27, 2014

Study Record Updates

• Last Update Posted (Estimate): February 27, 2014
• Last Update Submitted That Met QC Criteria: February 26, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Frailty; Sarcopenia
• Other Study ID Numbers: 201010021R; EC0991002-E (Registry Identifier: NHRI EC0991002-E)