UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063607 |
|---|---|
| Receipt number | R000072794 |
| Scientific Title | Do temporal patterns of daily physical activity (step count) modify the progression of cardiovascular-kidney-metabolic (CKM) syndrome? A longitudinal study using the DeSC database |
| Date of disclosure of the study information | 2026/11/12 |
| Last modified on | 2026/11/12 15:07:02 |
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Basic information
Public title
Study on the association between daily step count patterns and progression of cardiovascular-kidney-metabolic syndrome
Acronym
STEP-CKM
Scientific Title
Do temporal patterns of daily physical activity (step count) modify the progression of cardiovascular-kidney-metabolic (CKM) syndrome? A longitudinal study using the DeSC database
Scientific Title:Acronym
STEP-CKM
Region
| Japan |
Condition
Condition
Cardiovascular-kidney-metabolic syndrome
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the distribution and transitions of the integrated CKM stage among Japanese adult insurees in the DeSC database (existing de-identified data), and to evaluate whether temporal patterns (trajectory groups) of daily step counts over about two years after baseline are associated with the time to subsequent CKM stage progression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression of the integrated CKM stage: the first health checkup at which the stage is at least one level higher than the stage at the baseline checkup (follow-up after the landmark; analyzed by baseline stage, with the overall progression across all stages as a supplementary measure).
Key secondary outcomes
1) Improvement of the CKM stage (one level or more). 2) Cardiovascular events (acute myocardial infarction, hospitalization for heart failure, stroke; exploratory and descriptive). 3) All-cause death (ascertained where the death flag is usable). 4) Prevalence and distribution by CKM stage. 5) Exploratory subgroup analysis of participants aged 65 years or older.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Insurees registered in the DeSC database (data from April 2014 to January 2026) who meet all of the following: 1) aged 20 years or older; 2) continuously enrolled for 12 months or more before baseline; 3) have the health checkup items needed for CKM staging (eGFR and urine protein); 4) have valid step-count records (20 or more days per month) in 10 or more of the 12 months before baseline and in 20 or more of the about 24 months after baseline; 5) have two or more health checkups.
Key exclusion criteria
1) Already at CKM stage 4 (clinical cardiovascular disease) at baseline (excluded from the analysis of the primary outcome only; included in the analyses of cardiovascular events and all-cause death). 2) Excessive missing health checkup data (eGFR or urine protein missing, or two or more other staging items missing). 3) Insufficient follow-up. 4) Type 1 diabetes. 5) Receiving renal replacement therapy.
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Fujikura |
Organization
Hamamatsu University School of Medicine
Division name
Internal Medicine 1
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka,
TEL
053-435-2261
tfuji@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Fujikura |
Organization
Hamamatsu University School of Medicine
Division name
Internal Medicine 1
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka,
TEL
053-435-2261
Homepage URL
tfuji@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine, Ethics Committee for Life Sciences and Medical Research
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka,
Tel
053-435-2680
rinri@hama-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
26-209
Org. issuing International ID_1
Hamamatsu University School of Medicine, Ethics Committee for Life Sciences and Medical Research
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 12 | 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
| 2026 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective longitudinal cohort study using existing de-identified data of the DeSC database (health checkups, claims, and step counts). Temporal patterns of daily step counts over about two years after baseline are classified by group-based trajectory modeling (GBTM), and the time to subsequent CKM stage progression is compared among the trajectory groups using the landmark method (Cox proportional hazards model or similar; by baseline stage; the reference group is the group maintaining high activity). As a sensitivity analysis, a marginal structural model with time-varying step counts is used. As aim 1, the distribution and transitions of the CKM stage are described. The approval number and the data provider are described in other fields. The actual number of participants after applying the eligibility criteria will be fixed after the analysis is completed. Details of the analytic definitions may be refined after the data are checked; any change will be added to this field with its date.
Management information
Registered date
| 2026 | Year | 11 | Month | 12 | Day |
Last modified on
| 2026 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072794
