UMIN-CTR Clinical Trial

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
Email	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
Email	imasuda@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Medical Foundation Kosei-kai Takeda Hospital The Health Check-up Center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053493