- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02073370
Clinical Evaluation, Biomarkers and Metabolomics of Sarcopenia in Frail Older Adults at Ambulatory Clinics (EC0991002-E)
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Domestic operation tool of sarcopenia for older adults
Tidsramme: Baseline
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Young health adults are recruited for measurement of body composition using bio impedance analysis in order to establish the norm of skeletal muscle index
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Baseline
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline in body composition during aging
Tidsramme: up to 2 years
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Using anthropometric measurements, and bio impedance analysis, the change in body composition are measured in the recruited older adults
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up to 2 years
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Compare metabolomics profiles in sarcopenic older adults and non-sarcopenic older adults
Tidsramme: up to 2 years
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Using the blood specimen, the metabolomics platform are set up to explore the new bio markers of sarcopenia in older adults
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up to 2 years
|
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The prognosis of sarcopenia in the older adults
Tidsramme: up to 2 years
|
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
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up to 2 years
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Ching-Yu Chen, MD, National Tiwan University, College of Medicine
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 201010021R
- EC0991002-E (Registry Identifier: NHRI EC0991002-E)
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