UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047205 |
|---|---|
| Receipt number | R000053846 |
| Scientific Title | Is diabetes mellitus a precipitating factor for muscle function loss due to bed rest |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2025/03/20 14:02:03 |
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Basic information
Public title
Is diabetes mellitus a precipitating factor for muscle function loss due to bed rest
Acronym
Is diabetes mellitus a precipitating factor for muscle function loss due to bed rest
Scientific Title
Is diabetes mellitus a precipitating factor for muscle function loss due to bed rest
Scientific Title:Acronym
Is diabetes mellitus a precipitating factor for muscle function loss due to bed rest
Region
| Japan |
Condition
Condition
vertebral compression fracture/diabetes mellitus
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identifying the Relationship between Muscle Function and Diabetes Mellitus in Resting and Recumbent Patients with Spinal Compression Fractures
Basic objectives2
Others
Basic objectives -Others
Identify changes in muscle mass during periods of rest(Comparison for each disease)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle mass/strength
Key secondary outcomes
Walking speed, grip strength, TUG, CS30, SPPB
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
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult and older patients with spinal compression fractures admitted to our orthopedic department.
Key exclusion criteria
Minors or those with serious cerebrovascular or respiratory disorders
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Toshinori |
| Middle name | |
| Last name | Kakihara |
Organization
Kinashi Obayashi Hospital, Medical Corporation Foundation
Division name
Department of Rehabilitation
Zip code
761-8024
Address
435-1, Fujii, kinashi-cho, Takamatsu City, Kagawa Prefecture
TEL
087-881-3631
sangyoureha@obayashihp.or.jp
Public contact
Name of contact person
| 1st name | Toshinori |
| Middle name | |
| Last name | Kakihara |
Organization
Kinashi Obayashi Hospital, Medical Corporation Foundation
Division name
Department of Rehabilitation
Zip code
761-8024
Address
435-1, Fujii, kinashi-cho, Takamatsu City, Kagawa Prefecture
TEL
087-881-3631
Homepage URL
sangyoureha@obayashihp.or.jp
Sponsor or person
Institute
Kinashi Obayashi Hospital, Medical Corporation Foundation
Institute
Department
Personal name
Funding Source
Organization
Japan Diabetes Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kinashi Obayashi Hospital, Medical Corporation Foundation
Address
435-1, Fujii, kinashi-cho, Takamatsu City, Kagawa Prefecture
Tel
087-881-3631
sangyoureha@obayashihp.or.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 | 03 | Month | 31 | 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 | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 20 | Day |
Other
Other related information
Measurements of muscle mass and other parameters will be taken during the resting period, and physical function will be tracked after the patient begins to wean and after discharge from the hospital.
Management information
Registered date
| 2022 | Year | 03 | Month | 17 | Day |
Last modified on
| 2025 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053846
