UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048056 |
|---|---|
| Receipt number | R000053493 |
| Scientific Title | Study on the construction of early diagnosis indicators and assessment panels for cerebrocardiovascular disease, sarcopenia and cognitive frailty in health checkup examinees. |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/06/14 14:47:29 |
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Basic information
Public title
Study on the construction of early diagnosis indicators and assessment panels for cerebrocardiovascular disease, sarcopenia and cognitive frailty in health checkup examinees.
Acronym
Elder-safe study
Scientific Title
Study on the construction of early diagnosis indicators and assessment panels for cerebrocardiovascular disease, sarcopenia and cognitive frailty in health checkup examinees.
Scientific Title:Acronym
Elder-safe study
Region
| Japan |
Condition
Condition
Ordinary people (health checkup examinees)
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effective early diagnosis methods and predictive indicators of sarcopenia and cognitive frailty as a risk of cerebrocardiovascular disease in health checkup examinees.
Basic objectives2
Others
Basic objectives -Others
To examine effective early diagnosis methods and predictive indicators of sarcopenia and cognitive frailty as a risk of cerebrocardiovascular disease in health checkup examinees.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Cerebrocardiovascular disease risk indices(Number of metabolic syndrome, abdominal obesity, total number of hypertension, diabetes, dyslipidemia)
Key secondary outcomes
Sarcopenia-related indicators (Skeletal muscle mass, handgrip strength)
Motor functions (Motor function analysis using zaRitz, 5-time chair standing test)
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Lower age limit: 40 years old
2. Gender: male and female
3. Health checkup examinees at the Health Check-up Center of the Takeda Hospital Group
4. Examinees who have provided written informed consent
Key exclusion criteria
1. Examinees with data deficiencies
2. Examinees with pacemakers
3. Female examinees who are suspected of being pregnant or pregnant
4. Examinees with defects in their limbs
5. Examinees judged by the principal investigator/statistical analysis staff to be inappropriate for statistical analysis in this study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masuda |
| Middle name | |
| Last name | Izuru |
Organization
Medical Foundation Kosei-kai Takeda Hospital
Division name
The Health Check-up Center
Zip code
600-8216
Address
3F Nippon Seimei Kyoto Mitsuketsu Building 608 Higashi Shiokoji-cho, Shiokoji-dori, Nishinotoin Higashi-iru, Shimogyo-ku, Kyoto
TEL
075-365-0825
imasuda@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Izuru |
| Middle name | |
| Last name | Masuda |
Organization
Medical Foundation Kosei-kai Takeda Hospital
Division name
The Health Check-up Center
Zip code
600-8216
Address
3F Nippon Seimei Kyoto Mitsuketsu Building 608 Higashi Shiokoji-cho, Shiokoji-dori, Nishinotoin Higa
TEL
075-365-0825
Homepage URL
imasuda@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Medical Foundation Kosei-kai Takeda Hospital
The Health Check-up Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital Organization Kyoto Medical Center, Doshisha University
Name of secondary funder(s)
National Hospital Organization Kyoto Medical Center
IRB Contact (For public release)
Organization
Medical Foundation Kosei-kai Takeda Hospital The Health Check-up Center
Address
3F Nippon Seimei Kyoto Mitsuketsu Building 608 Higashi Shiokoji-cho, Shiokoji-dori, Nishinotoin Higa
Tel
075-365-0825
imasuda@kuhp.kyoto-u.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
| 2022 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Main observation items
1. Sarcopenia-related indicators, skeletal muscle mass, muscle strength, phase angle, and myokines
Other observation items
1. Background, age, sex, height
2. Diet, exercise, and lifestyle, Specific health checkup questionnaire, smoking and drinking habits, diet, and exercise habits
3. Medical history, complications
4. Medication
5. Blood pressure, pulse rate
6. Obesity-related indicators, body weight, BMI, waist circumference, body fat, A body shape index, body roundness index, visceral fat area
7. Glucose and lipid metabolism indicators, fasting blood glucose, HbA1c, triglyceride, high Density Lipoprotein Cholesterol, low Density Lipoprotein Cholesterol
8. Liver function indicators, ALT, AST, gamma Glutamyl Trans Peptidase, fatty liver
9. Renal function indicators, BUN, Cre, eGFR
10. General blood tests, white blood cell count, hemoglobin, platelet count, CRP count, total bilirubin
11. Special blood tests, BNP, N terminal pro-brain natriuretic peptide, TREM2, adipocytokines such as leptin, adiponectin
12. Arterial stiffness indicator, Pulse Wave Velocity
Management information
Registered date
| 2022 | Year | 06 | Month | 14 | Day |
Last modified on
| 2022 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053493
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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