- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02073370
Clinical Evaluation, Biomarkers and Metabolomics of Sarcopenia in Frail Older Adults at Ambulatory Clinics (EC0991002-E)
Studieoversikt
Status
Forhold
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
-
Taipei, Taiwan, 100
- National Taiwan University Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Domestic operation tool of sarcopenia for older adults
Tidsramme: Baseline
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change from baseline in body composition during aging
Tidsramme: up to 2 years
|
Using anthropometric measurements, and bio impedance analysis, the change in body composition are measured in the recruited older adults
|
up to 2 years
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Compare metabolomics profiles in sarcopenic older adults and non-sarcopenic older adults
Tidsramme: up to 2 years
|
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
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
|
up to 2 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Ching-Yu Chen, MD, National Tiwan University, College of Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 201010021R
- EC0991002-E (Registeridentifikator: NHRI EC0991002-E)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .