UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054792 |
|---|---|
| Receipt number | R000062563 |
| Scientific Title | AIST and Kagawa University Hospital jointly conduct research on walking function and sarcopenia in elderly diabetic patients |
| Date of disclosure of the study information | 2024/06/26 |
| Last modified on | 2024/06/26 23:49:37 |
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Basic information
Public title
Research on walking function and sarcopenia in elderly diabetic patients
Acronym
Research on walking function and sarcopenia in elderly diabetic patients
Scientific Title
AIST and Kagawa University Hospital jointly conduct research on walking function and sarcopenia in elderly diabetic patients
Scientific Title:Acronym
AIST and Kagawa University Hospital jointly conduct research on walking function and sarcopenia in elderly diabetic patients
Region
| Japan |
Condition
Condition
Type 2 diabetes
Sarcopenia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will compare the effect of sarcopenia on walking function in elderly patients with type 2 diabetes mellitus in a group with sarcopenia and a group without sarcopenia.
Basic objectives2
Others
Basic objectives -Others
Walking function
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Walking function (parameters obtained by analysis using motion capture technology: walking speed, stride length, range of motion and sway of each joint, etc.)
Key secondary outcomes
Treatment status of diabetes mellitus (blood glucose, HbA1c)
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
Type 2 diabetes patients over 65 years old
Independent in ADL (activities of daily living)
Key exclusion criteria
Patients with frequent hypoglycemia
Patients with pre-existing walking dysfunction due to cerebrovascular or neurological disease
Patients participating in other clinical trials
Patients with severe renal dysfunction (serum creatinine > 1.5 mg/dl)
Patients with severe diabetic neuropathy
Patients with other serious complications
Patients who are judged to be inappropriate for the study by the physician's judgment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Kobayashi |
Organization
Kagawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
761-0793
Address
1750-1, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-898-5111
kobayashi.toshihiro@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiro |
| Middle name | |
| Last name | Kobayashi |
Organization
Kagawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
761-0793
Address
1750-1, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-898-5111
Homepage URL
kobayashi.toshihiro@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Kagawa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute of Advanced Industrial Science and Technology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Faculty of Medicine, Kagawa University
Address
1750-1, Miki-cho, Kita-gun, Kagawa, Japan
Tel
087-898-5111
md-chiken@kagawa-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
| 2024 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Study conducted on type 2 diabetes patients aged 65 years or older attending the Department of Endocrinology and Metabolism, Kagawa University Hospital
Management information
Registered date
| 2024 | Year | 06 | Month | 26 | Day |
Last modified on
| 2024 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062563
