UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056420 |
|---|---|
| Receipt number | R000064466 |
| Scientific Title | Changes in metabolic risk parameters of over-weight athletes before and after leaving their sports clubs |
| Date of disclosure of the study information | 2024/12/10 |
| Last modified on | 2024/12/10 20:12:25 |
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Basic information
Public title
Changes in metabolic risk parameters of over-weight athletes before and after leaving their sports clubs
Acronym
Changes in metabolic risk parameters of over-weight athletes before and after leaving their sports clubs
Scientific Title
Changes in metabolic risk parameters of over-weight athletes before and after leaving their sports clubs
Scientific Title:Acronym
Changes in metabolic risk parameters of over-weight athletes before and after leaving their sports clubs
Region
| Japan |
Condition
Condition
metabolic risks such as metabolic syndrome, insulin resistance, etc.
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the changes in metabolic risk parameters of over-weight athletes before and after leaving their sports clubs
Basic objectives2
Others
Basic objectives -Others
1-year observation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Metabolic syndrome, insulin resistance, cross-sectional area of visceral adipose tissue, accmulation of ectopic adipose tissue
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
| 21 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
Male college students who were 4th year athletes and body mass index: >26 kg/m2 or more or weight >85 kg) and male college students who were 4th year and not affiliated with any sports clubs.
Key exclusion criteria
People whose age were under 20 years, with metal objects or other artificial objects such as cardiac pacemakers, artificial heart valves, cerebral artery tumor metal clips, artificial joints, cochlear implants, magnetically removable dentures, etc. in their bodies, with tattoos or permanent makeup, with claustrophobia, with exercise restrictions. In the case of second measurement, people who have continued the above exercise for more than one year at least twice a week for 30 minutes or more per session even after retiring from sports clubs
Target sample size
40
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, & Sports
Zip code
4648601
Address
Furo-cho, Chikusa-ku, Nagoya-shi, Aichi
TEL
0527893948
tanaka-n@htc.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | Ishiguro |
| 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-shi, Aichi
TEL
0527893948
Homepage URL
tanaka-n@htc.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Noriko Ishiguro Tanaka
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee of the Nagoya University Graduate School of Medicine and Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8560
Tel
052-744-2479
tanaka-n@htc.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2018-0250
Org. issuing International ID_1
Committee of the Nagoya University Graduate School of Medicine and Nagoya University Hospital
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 | 12 | Month | 10 | Day |
Related information
URL releasing protocol
https://nagoya.bvits.com/rinri/publish_document.aspx?TYPE=1&ID=5848&VERSION=0&DOC_TYPE=12&PDF=1
Publication of results
Unpublished
Result
URL related to results and publications
https://nagoya.bvits.com/rinri/publish_document.aspx?TYPE=1&ID=5848&VERSION=0&DOC_TYPE=12&PDF=1
Number of participants that the trial has enrolled
32
Results
At baseline as well as at 1 year follow-up, 68.8 percent of athletes had at least one abnormal cardiometabolic risk factor, including blood pressure, glucose metabolism index, and liver function. Body weight and trunk skeletal muscle cross-sectional area of athletes decreased significantly over 1 year, but subcutaneous fat area, visceral fat area, and intramuscular fat accumulation did not change significantly.
Results date posted
| 2024 | Year | 12 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The 4th year athletes (body mass index: 26 kg/m2 or more or weight 85 kg or more) who belong to a university sports club, and 4th year university students who do not have exercise habits.
Participant flow
One-year observation
Adverse events
none
Outcome measures
Changes in matabolic risk factors, trunk tissue distribution, body composition, dietary intakes
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 12 | Month | 10 | Day |
Last modified on
| 2024 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064466
