UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059199 |
|---|---|
| Receipt number | R000067707 |
| Scientific Title | A Study on the Correlation Between HbA1c Levels and Glycated Albumin Levels in Blood and Saliva Using Average Blood Glucose Levels |
| Date of disclosure of the study information | 2025/09/30 |
| Last modified on | 2025/09/26 10:54:45 |
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Basic information
Public title
A Study on the Correlation Between HbA1c Levels and Glycated Albumin Levels in Blood and Saliva Using Average Blood Glucose Levels
Acronym
A Study on the Correlation Between HbA1c Levels and Glycated Albumin Levels in Blood and Saliva Using Average Blood Glucose Levels
Scientific Title
A Study on the Correlation Between HbA1c Levels and Glycated Albumin Levels in Blood and Saliva Using Average Blood Glucose Levels
Scientific Title:Acronym
A Study on the Correlation Between HbA1c Levels and Glycated Albumin Levels in Blood and Saliva Using Average Blood Glucose Levels
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have reported on the usefulness of diabetes management methods using glycated albumin (GA) levels, which reflect average blood glucose levels over the preceding few weeks.
However, evidence regarding diabetic complications has primarily been reported using HbA1c levels, necessitating clarification of the relationship between HbA1c and GA levels.
In recent years, continuous glucose monitoring (CGM) has enabled detailed assessment of blood glucose fluctuations over a specific period.
Therefore, we decided to use CGM to measure average blood glucose levels and conduct a detailed analysis of the correlation between HbA1c levels and GA levels in blood and saliva.
Basic objectives2
Others
Basic objectives -Others
Same as above
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Week 0: height, weight, waist circumference, medication details, fasting blood glucose level, HbA1c level, GA level, liver function, kidney function, anemia, urinalysis
Week 4: height, weight, waist circumference, medication details, fasting blood glucose level, HbA1c level, GA level, liver function, kidney function, anemia
Week 8: height, weight, waist circumference, medication details, fasting blood glucose level, HbA1c level, GA level, liver function, kidney function, anemia
Throughout the entire period: CGM, weekly GA level
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Male and female aged 20 years or older
- Diabetes patients with HbA1c of 6% or higher (type of diabetes not specified)
- Participants capable of self-installing a CGM sensor and owning a smartphone compatible with the CGM app, as well as installing and using the app
- Participants capable of self-collecting fingerstick blood and saliva samples and mailing them
Key exclusion criteria
- Participants who do not wish to be informed of any unexpected findings
- Participants with HbA1c levels below 6% in screening tests
- Participants testing positive for HIV, hepatitis B, hepatitis C, or syphilis in infectious disease tests
- Participants with conditions affecting HbA1c or GA levels (e.g., blood disorders, liver/kidney disease)
- Participants deemed unable to continue participation following a physician's examination
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Sakurai |
Organization
The University of Tokyo Hospital
Division name
Department of Diabetes and Metabolic Diseases
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
maihara-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Aihara |
Organization
The University of Tokyo Hospital
Division name
Department of Diabetes and Metabolic Diseases
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
maihara-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
New Energy and Industrial Technology Development Organization
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
Office for Human Research Studies(OHRS), Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.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 | 09 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An 8-week observational study.
Participants will visit the hospital at weeks 0, 4, and 8 for physical measurements, blood tests, and other procedures.
During the observation period, CGM and weekly GA monitoring will be conducted.
Management information
Registered date
| 2025 | Year | 09 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067707
