UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052300 |
|---|---|
| Receipt number | R000059706 |
| Scientific Title | Observational study on the relationship between mood and blood glucose level (SIC-2023-01-BLGFG) |
| Date of disclosure of the study information | 2023/09/26 |
| Last modified on | 2024/09/25 11:35:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Observational study on the relationship between mood and blood glucose level
Acronym
Observational study on the relationship between mood and blood glucose level
Scientific Title
Observational study on the relationship between mood and blood glucose level
(SIC-2023-01-BLGFG)
Scientific Title:Acronym
Observational study on the relationship between mood and blood glucose level
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between mood and blood glucose level
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between mood and blood glucose level
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective assessments of mood
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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Subjects who can make self-judgment and are voluntarily giving written informed consent.
(2) From 20 to 64 years healthy men and women.
(3) Subjects who can take online explanations and tests.
(4) Subjects who can visit the facility on designated day.
Key exclusion criteria
(1) Subjects whose systolic blood pressure is less than 90mmHg
(2) Subjects who wish to become pregnant during the examination period, or in pregnancy or lactation
(3) Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks, or planning to participate during the study period.
(4) Subjects who are applicable to following items;
a) Subjects with disease on heart, liver, kidney or other organs complication.
b) Subjects with a previous history of disease on circulatory organs.
c) Subjects who are contracting diabetes.
d) Subjects undergoing treatment for or with a history of cancer, tuberculosis, or other serious illness
(5) Subjects whose BMI is less than 18.5 or over 25.0 kg/m2.
(6) Smokers.
(7) Subjects who drink a lot.
(8) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Akifumi |
| Middle name | |
| Last name | Maeda |
Organization
Suntory Global Innovation Center Ltd.
Division name
Research Institute
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0719
Akifumi_Maeda@suntory.co.jp
Public contact
Name of contact person
| 1st name | Natsumi |
| Middle name | |
| Last name | Hiraki |
Organization
Suntory Global Innovation Center Ltd.
Division name
Research Institute
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0561
Homepage URL
Natsumi_Hiraki@suntory.co.jp
Sponsor or person
Institute
Suntory Global Innovation Center Ltd.
Institute
Department
Personal name
Funding Source
Organization
Suntory Holdings Ltd.
Suntory Global Innovation Center Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Bldg. 3-3-10, Nihonbashi Hongokucho, Chuo-ku, Tokyo, Japan
Tel
03-6225-9005
IRB@cpcc.co.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
| 2023 | Year | 09 | Month | 26 | 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
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2023 | Year | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059706
