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

NCT02073370 | Unknown

• 2 other identifiers: 201010021REC0991002-E
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Frailty; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline in body composition during aging

  up to 2 years

Other Outcomes (2)

• Compare metabolomics profiles in sarcopenic older adults and non-sarcopenic older adults

  up to 2 years

• The prognosis of sarcopenia in the older adults

  up to 2 years

Study Arms (1)

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.

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Health Research Institutes, Taiwan: collaborator
• National Taiwan University: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Frailty; Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

• Ching-Yu Chen, MD

  National Tiwan University, College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: February 27, 2014
• Study Start: January 1, 2011
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 27, 2014

Record last verified: 2014-02

Locations

TW (1)