Clinical Evaluation, Biomarkers and Metabolomics of Sarcopenia in Frail Older Adults at Ambulatory Clinics

Sarcopenia Clinical Trial

— EC0991002-E  

Official title:

Clinical Evaluation, Biomarkers and Metabolomics of Sarcopenia in Frail Older Adults at Ambulatory Clinics

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02073370
• Other study ID #: 201010021R
• Secondary ID: EC0991002-E
• Status: Active, not recruiting
• Phase: N/A
• First received: August 30, 2011
• Last updated: February 26, 2014
• Start date: January 2011
• Est. completion date: December 2018

Study information

• Verified date: February 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Frailty
• Sarcopenia

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (3)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Health Research Institutes, Taiwan, National Taiwan University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Primary	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	No
Secondary	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	No