UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057655 |
|---|---|
| Receipt number | R000065877 |
| Scientific Title | Is sleep state related to arterial stiffness following a postprandial rise in blood glucose level? |
| Date of disclosure of the study information | 2025/04/19 |
| Last modified on | 2025/11/27 00:03:21 |
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Basic information
Public title
Is sleep state related to arterial stiffness following a postprandial rise in blood glucose level?
Acronym
Is sleep state related to arterial stiffness following a postprandial rise in blood glucose level?
Scientific Title
Is sleep state related to arterial stiffness following a postprandial rise in blood glucose level?
Scientific Title:Acronym
Is sleep state related to arterial stiffness following a postprandial rise in blood glucose level?
Region
| Japan |
Condition
Condition
Arteriosclerosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of sleep state on arterial stiffness associated with postprandial blood glucose rise in middle-aged and elderly men and women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Day 1 of Measurement
The study is explained to the participant, and written consent is obtained. To assess autonomic nervous function, a wearable heart rate sensor and electrodes are attached to the chest (female examiner for female participants). For physical activity and sleep monitoring, a wrist-worn accelerometer is attached. Participants follow their usual daily routine but are asked to avoid intense exercise, alcohol, and food or drink (except water) after 9:00 PM. Devices should be removed only during bathing and reattached immediately. All measurements are automatic, and the examiner will respond to any issues.
Day 2 of Measurement
The next morning, participants return in a fasted state. Height, weight, body fat percentage, and BMI are measured. A 75g oral glucose tolerance test (OGTT) is performed, and vascular stiffness, blood pressure, heart rate, blood glucose, and autonomic function are assessed at baseline, 60, and 120 minutes post-ingestion. Questionnaires on sleep, physical activity, and dietary habits are also completed. Total time is approximately 2.5 to 3 hours. All procedures follow relevant professional guidelines.
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Schedule can be adjusted
2) Body mass index (BMI) is less than 18.5 to 25 kg / m2
3) You can follow the precautions when participating in the experiment
4) No smoking habits
5) Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1) If you have a chronic disease
2) When the subject has severe physical symptoms and it is difficult to cooperate with the research
3) In addition, if the person in charge of the survey judges it inappropriate to participate
Target sample size
165
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Kobayashi |
Organization
Teikyo University of Science
Division name
Center for Arts and Sciences
Zip code
120-0045
Address
2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan
TEL
03-6910-1010
rkobayashi@ntu.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Kobayashi |
Organization
Teikyo University of Science
Division name
Center for Arts and Sciences
Zip code
120-0045
Address
2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan
TEL
03-6910-1010
Homepage URL
rkobayashi@ntu.ac.jp
Sponsor or person
Institute
Center for Arts and Sciences, Teikyo University of Science
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
Teikyo University of Science
Address
2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan
Tel
03-6910-1010
kenkyushien@ntu.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
| 2025 | Year | 04 | Month | 19 | 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
100
Results
The brachial-ankle pulse wave velocity (baPWV) in the poor sleep quality group significantly increased 60 min after the 75-g oral glucose tolerance test (OGTT) compared to before the test (P<0.01), whereas no change was observed in the good sleep quality group. baPWV before and 60 min after the 75-gOGTT was significantly higher in the poor sleep quality group compared to the good sleep quality group (P<0.05).
Results date posted
| 2025 | Year | 10 | Month | 18 | Day |
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
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Although no direct benefit is expected for the participants, this study may contribute to generalizable knowledge regarding health conditions. The study will be conducted using devices whose safety has been confirmed through operational checks and will follow hygienic procedures commonly practiced in research or clinical settings, with consideration for participants' well-being.
Measurement of arterial stiffness carries a very low risk of temporary numbness in the arm. Finger-prick blood glucose testing may cause mild pain, which in rare cases could lead to dizziness, lightheadedness, or loss of consciousness. After ingestion of the 75g glucose solution, some participants may experience nausea, headache, vomiting, diarrhea, abdominal bloating, or abdominal pain.
In principle, no significant physical or psychological burden is expected during data collection. However, if a participant feels unwell or their condition suddenly changes, the measurement will be immediately stopped, appropriate care will be provided - including possible hospital transport - and the participant will be monitored until recovery.
Management information
Registered date
| 2025 | Year | 04 | Month | 19 | Day |
Last modified on
| 2025 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065877
