UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061667 |
|---|---|
| Receipt number | R000070558 |
| Scientific Title | An Investigation into the Prevalence of Hypoglycemia Among Young Female Athletes and Its Association with Lifestyle Habits Characteristic of Chronotypes |
| Date of disclosure of the study information | 2026/05/22 |
| Last modified on | 2026/05/22 22:39:30 |
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Basic information
Public title
An Investigation into the Actual Occurrence of Hypoglycemia Among Young Female Athletes and Its Association with Lifestyle Habits Characteristic of Morning and Evening Types
Acronym
A Study on Hypoglycemia and Morning vs. Evening Types Among Young Female Athletes
Scientific Title
An Investigation into the Prevalence of Hypoglycemia Among Young Female Athletes and Its Association with Lifestyle Habits Characteristic of Chronotypes
Scientific Title:Acronym
A Study on Hypoglycemia and Chronotype in Young Female Athletes
Region
| Japan |
Condition
Condition
Hypoglycemia
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the occurrence of hypoglycemia in young female athletes is associated with lifestyle habits characteristic of their chronotype
Basic objectives2
Others
Basic objectives -Others
Observational Study of Biochemical Data
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in flash glucose levels over a 2-week period as measured by CGM
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
| 15 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Female
Key inclusion criteria
Young female athletes who primarily reside or train in the Kanto region and its neighboring prefectures, and who face time constraints due to school, work, or other social commitments outside of their athletic activities, and who regularly participate in early-morning training
Key exclusion criteria
Individuals who are being monitored for blood glucose fluctuations using an interstitial fluid glucose monitoring system, and who are currently being treated for a condition that affects blood glucose levels (such as diabetes) or are under regular medical observation due to suspected diagnosis of such a condition
Individuals who are unable to engage in normal athletic activities due to illness, injury, or are in the post-surgical rehabilitation period
Individuals using implantable medical devices, such as pacemakers
Individuals scheduled to undergo an MRI scan during the measurement period (participation is possible if the timing of the scan can be rescheduled)
Individuals using pralidoxime potassium (an antidote for organophosphate poisoning) may exhibit abnormal flash glucose readings; therefore, measurement will be discontinued
Due to the need to wear the device during measurement, athletes participating in combat sports such as judo or wrestling, which involve intense physical contact, impact with the ground, or friction, as well as sports with frequent collisions, such as rugby tackles
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | HIROKO |
| Middle name | |
| Last name | MURATA |
Organization
Jumonji University
Division name
Department of Health and Nutrition
Zip code
3528510
Address
2-1-28 Sugasawa Niiza Saitama
TEL
0484770555
murata@jumonji-u.ac.jp
Public contact
Name of contact person
| 1st name | HIROKO |
| Middle name | |
| Last name | MURATA |
Organization
Jumonji University
Division name
Department of Health and Nutrition
Zip code
3528510
Address
2-1-28 Sugasawa Niiza Saitama
TEL
0484770555
Homepage URL
murata@jumonji-u.ac.jp
Sponsor or person
Institute
Jumonji University
Institute
Department
Personal name
Funding Source
Organization
Jumonji University
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
Jumonji University
Address
2-1-28 Sugasawa Niiza Saitama
Tel
0484770555
murata@jumonji-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
| 2026 | Year | 05 | Month | 22 | 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
32
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study is a cross-sectional observational study. The study population consists of all young female student athletes (members of university or high school sports teams or club teams) recruited through convenience sampling between 2023 and 2025 who met the inclusion criteria. The measurement items include:(1) sleep-wake rhythms, such as chronotype (MEQ), sleepiness(KSS), and sleep quality (PSQI); (2) questionnaires on lifestyle habits, physical condition, menstrual status, and injury history; (3) anthropometric measurements (height, weight, body fat percentage, and estimated bone mass); (4) Nutritional intake (FFQJA, food diary + photos),(5) Physical activity levels and energy expenditure (factor-based scoring based on daily activity logs, triaxial accelerometer), and (6)Blood glucose variability (FreeStyle Libre). The study period will run from the date of ethical review approval through March 2026, with measurements to be completed by March 2025.
Management information
Registered date
| 2026 | Year | 05 | Month | 22 | Day |
Last modified on
| 2026 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070558
