UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043133 |
|---|---|
| Receipt number | R000049240 |
| Scientific Title | Juntendo Sarcopenia registration of exploring for predidtors and prognosis in Elderly-in TOKYO |
| Date of disclosure of the study information | 2021/01/26 |
| Last modified on | 2022/01/27 11:49:18 |
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Basic information
Public title
Juntendo Sarcopenia registration of exploring for predidtors and prognosis in Elderly-in TOKYO
Acronym
Juntendo Sarcopenia registration of exploring for predidtors and prognosis in Elderly-in TOKYO
Scientific Title
Juntendo Sarcopenia registration of exploring for predidtors and prognosis in Elderly-in TOKYO
Scientific Title:Acronym
Juntendo Sarcopenia registration of exploring for predidtors and prognosis in Elderly-in TOKYO
Region
| Japan |
Condition
Condition
Sarcopenia, Frail
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Clinical immunology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the frequency and predictors of sarcopenia in patients aged 65 years and older with cardiovascular disease, digestive disease, respiratory disease, collagen disease, diabetes and metabolic endocrine disease.
Basic objectives2
Others
Basic objectives -Others
Examine the prognosis and prognostic factors of sarcopenia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
･Incidence rate of events (death and hospitalization) with or without sarcopenia
･Comparison of time to onset of event (death and hospitalization) with or without sarcopenia
･ Analysis of event predictors (both death and hospitalization)
･ The above analysis with and without frail
Key secondary outcomes
･Major bleeding, clinically significant non-major bleeding, cardiovascular death, hospitalization due to heart failure, non-fatal myocardial infarction, coronary revascularization, peripheral angiopathy, intracranial hemorrhage, cerebral infarction, transient ischemic attack Attacks, new cancers, number of falls, fractures, gastrointestinal hemorrhage, hospitalization for pneumonia, increased dose of dementia drugs with or without sarcopenia.
･Examination of risk factors for sarcopenia
Univariate analysis of risk factors for elderly sarcopenia and multiple logistics with the examination items (questionnaire, questionnaire, blood test, diagnostic imaging, physiological function test, muscle strength measurement) as explanatory variables and the presence or absence of elderly sarcopenia as the objective variable. Consider by analysis. Patient background Questionnaire / Questionnaire / Blood data / Physical measurement (including BIA data) / Skeletal muscle mass measurement (DEXA) / ECG / ABI / Respiratory function measurement data and cardiovascular / digestive / respiratory symptoms / disease It also analyzes.
･Incidence of secondary endpoints depending on the presence or absence of sarcopenia and frailty
･Incidence rate of secondary endpoints by patient background
･Incidence of secondary endpoints by disease in each department
･Analysis of occurrence predictors of secondary endpoints
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Regular outpatient visits to cardiology, gastroenterology, respiratory medicine, diabetic endocrinology, and collagen disease internal medicine
2. 65 years old and over
3. Independent walking (including walking with a cane)
4. Patients who have consented to participate in the research
Key exclusion criteria
1.Patients who cannot walk independently or cannot listen to interviews / questionnaires
2.Patients with serious cerebrovascular disease, heart disease, respiratory disease, liver disease, renal disease, digestive disease, endocrine and metabolic disease
3. Patients whose life expectancy is judged to be within one year due to malignant diseases, etc.
4. Patients judged by the attending physician to be ineligible
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Asaoka |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
136-0075
Address
3-3-20, Shinsuna, Koto-ku, Tokyo
TEL
03-5632-3111
daisuke@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Matsuno |
Organization
Juntendo Tokyo Koto Geriatric Medical Center
Division name
Department of Respiratory Medicine
Zip code
136-0075
Address
3-3-20, Shinsuna, Koto-ku, Tokyo
TEL
03-5632-3111
Homepage URL
kmatsuno@juntendo.ac.jp
Sponsor or person
Institute
Juntendo Tokyo Koto Geriatric Medical Center
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo Tokyo Koto Medical Center for the Elderly Ethics Committee, Juntendo University School of Medicine
Address
3-3-20, Shinsuna, Koto-ku, Tokyo
Tel
03-5632-3111
kmatsuno@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observationa
Management information
Registered date
| 2021 | Year | 01 | Month | 26 | Day |
Last modified on
| 2022 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049240
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| Research case data | |
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