UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055957 |
|---|---|
| Receipt number | R000063947 |
| Scientific Title | Establishment of a new evaluation method for amount of skeletal muscle considering intramuscular adipose tissue content - A study using ultrasound imaging |
| Date of disclosure of the study information | 2024/10/29 |
| Last modified on | 2025/03/22 21:33:47 |
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Basic information
Public title
Establishment of a new evaluation method for amount of skeletal muscle considering intramuscular adipose tissue content - A study using ultrasound imaging
Acronym
Establishment of a new evaluation method for amount of skeletal muscle considering intramuscular adipose tissue content - A study using ultrasound imaging
Scientific Title
Establishment of a new evaluation method for amount of skeletal muscle considering intramuscular adipose tissue content - A study using ultrasound imaging
Scientific Title:Acronym
Establishment of a new evaluation method for amount of skeletal muscle considering intramuscular adipose tissue content - A study using ultrasound imaging
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establish a new evaluation method using ultrasound imaging that takes into account the accumulation of non-contractile elements, mainly intramuscular fat, within skeletal muscle in the evaluation of muscle thickness, an indicator of skeletal muscle mass.
Basic objectives2
Others
Basic objectives -Others
Comparison between tradional muscle thickness measurements and corrected muscle thickness values reflecting intramuscular fat content in relation to physical function and risk factors for metabolic syndrome.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between the cross-sectional area of skeletal muscle tissue and intramuscular fat accumulation evaluated using magnetic resonance imaging (MRI) of the thigh and trunk, and muscle thickness and echo intensity evaluated from echo images taken of the same areas.
Key secondary outcomes
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
| 18 | years-old | < |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have no difficulty in daily life and are not under treatment for cardiovascular, respiratory, or orthopedic diseases.
Men and women (no possibility of pregnancy)
18-79 years old
Those who have signed the consent form of their own free will after understanding the study contents.
Key exclusion criteria
Persons who have a conflict of interest with researchers.
Patients with diseases that absolutely contraindicate exercise.
Persons with contraindications to MRI imaging.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Tanaka |
Organization
Nagoya University
Division name
Research Center of Health Physical Fitness and Sports
Zip code
4648601
Address
Furo-cho, Chikusa-ku, Nagoya, Aichi
TEL
0527893948
tanaka-n@htc.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Tanaka |
Organization
Nagoya University
Division name
Research Center of Health Physical Fitness and Sports
Zip code
4648601
Address
Furo-cho, Chikusa-ku, Nagoya, Aichi
TEL
0527893948
Homepage URL
tanaka-n@htc.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Health and Sports Ethics Committee at Nagoya University
Address
Furo-cho, Chikusa, Nagoya, Aichi
Tel
0527893946
htc-rinri@adm.nagoya-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 | 10 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cross-sectional study
Management information
Registered date
| 2024 | Year | 10 | Month | 27 | Day |
Last modified on
| 2025 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063947
