UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062910 |
|---|---|
| Receipt number | R000072029 |
| Scientific Title | An observational study of sarcopenia risk assessment and glycemic management in patients aged 65 years or older patients with type 2 diabetes |
| Date of disclosure of the study information | 2026/09/16 |
| Last modified on | 2026/09/14 10:41:04 |
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Basic information
Public title
An observational study of sarcopenia risk assessment and glycemic management in patients aged 65 years or older patients with type 2 diabetes
Acronym
SARCO-DM Study
Scientific Title
An observational study of sarcopenia risk assessment and glycemic management in patients aged 65 years or older patients with type 2 diabetes
Scientific Title:Acronym
SARCO-DM Study
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively examine glycemic management (HbA1c) over 48 weeks, as assessed by HbA1c, according to sarcopenia risk status using the finger-ring test in older patients with type 2 diabetes mellitus. In addition, the proportion and characteristics of patients at risk of sarcopenia will be investigated.
Basic objectives2
Others
Basic objectives -Others
Descriptive assessment of glycemic management status in elderly patients with type 2 diabetes mellitus at risk of sarcopenia
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cross-tabulation of worsening vs improvement/maintenance groups based on HbA1c category classification in 0.5% increments from baseline to 48 weeks (comparison between sarcopenia risk group vs no-risk group, and subgroups by fall history)
Key secondary outcomes
- Cross-tabulation of worsening vs improvement/maintenance groups based on HbA1c category classification in 0.5% increments from baseline to 48 weeks.
- HbA1c values and changes from baseline at each assessment (12, 24, 36, 48 weeks)
- Proportion of patients with HbA1c >=7% or >=8% at each assessment.
- Proportion with changes in antidiabetic medications from baseline to each assessment, including addition/switching or dose increase.
- Time to first change in antidiabetic medication from baseline to week 48; participants without a change will be counted as 48 weeks.
- Proportion and cumulative number of responses reporting hypoglycemia at each assessment.
- Proportion and cumulative number of responses reporting falls at each assessment.
- Proportion answering yes to each item of the Kihon Checklist at baseline and week 48.
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) Aged 65 years or older at the time of consent
2) Diagnosed with type 2 diabetes mellitus by a physician
3) Prescribed diabetes medication
4) Understood the web-based explanation and provided voluntary informed consent to participate
Key exclusion criteria
None
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Narita |
Organization
Sumitomo Pharma Co., Ltd.
Division name
Medical Affairs Department
Zip code
103-6012
Address
Tokyo Nihonbashi Tower, 2-7-1 Nihonbashi, Chuo-ku, Tokyo, Japan
TEL
080-4653-2821
yuki.narita@sumitomo-pharma.co.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Saika |
Organization
KAKEHASHI Inc.
Division name
Patient Engagement
Zip code
177-0042
Address
Sumitomo Fudosan Hibiya Bldg., 5th Floor 2-8-6, Nishishinbashi, Minato-ku, Tokyo, Japan
TEL
03-6825-2058
Homepage URL
SARCO_Study@kakehashi.life
Sponsor or person
Institute
Sumitomo Pharma Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
KAKEHASHI Inc.
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Research Ethics Committee of Sumitomo Pharma Co., Ltd.
Address
2-6-8 Doshomachi, Chuo-ku, Osaka, Japan
Tel
06-6203-5321
kenkyu-rinri@sumitomo-pharma.co.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
該当なし／Not applicable
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 16 | 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 | 07 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2026 | Year | 09 | Month | 14 | Day |
Last modified on
| 2026 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072029
