UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056857 |
|---|---|
| Receipt number | R000064990 |
| Scientific Title | Blood Glucose Screening in Dental Clinics for Early Detection of Diabetes and Prediabetes: A Multicenter Prospective Cohort Study |
| Date of disclosure of the study information | 2025/01/29 |
| Last modified on | 2025/01/29 16:56:17 |
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Basic information
Public title
Blood Glucose Screening in Dental Clinics for Early Detection of Diabetes and Prediabetes
Acronym
Blood Glucose Measurement in Dental Clinics
Scientific Title
Blood Glucose Screening in Dental Clinics for Early Detection of Diabetes and Prediabetes: A Multicenter Prospective Cohort Study
Scientific Title:Acronym
Blood Glucose Measurement in Dental Clinics
Region
| Japan |
Condition
Condition
Periodontitis, Dental caries, Alveolar abscess
Classification by specialty
| Endocrinology and Metabolism | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure blood glucose levels in dental clinic patients, identify the prevalence of diabetes and prediabetes, explore the factors associated with these conditions, and characterize patients at high risk for diabetes in the dental clinic setting.
Basic objectives2
Others
Basic objectives -Others
Early detection of diabetes and prediabetes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of positive blood glucose screening in dental clinic patients
Key secondary outcomes
Identification of factors associated with positive blood glucose screening and evaluation of diagnostic performance through a combination of associated factors
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Japanese individuals aged 18 years or older at the time of consent acquisition
Key exclusion criteria
People undergoing treatment for diabetes
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Kyoichiro |
| Middle name | |
| Last name | Tsuchiya |
Organization
University of Yamanashi Graduate School
Division name
Department of Diabetes and Endocrinology
Zip code
409-3898
Address
1110 Shimokato, Chuo-shi, Yamanashi
TEL
055-273-3310
tsuchiyak@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Harai |
Organization
University of Yamanashi Graduate School
Division name
Department of Diabetes and Endocrinology
Zip code
409-3898
Address
1110 Shimokato, Chuo-shi, Yamanashi
TEL
0552733310
Homepage URL
knozomi@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
No funding organization
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
University of Yamanashi
Address
University of Yamanashi
Tel
055-273-1111
rec-med@yamanashi.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 | 01 | Month | 29 | 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
749
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 | 05 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In dental clinic patients, blood glucose levels are measured from the fingertip, and an oral examination is performed. Blood glucose screening is considered positive if fasting blood glucose is 100 mg/dL or higher, or if non-fasting blood glucose is 140 mg/dL or higher. Patients with positive blood glucose screening are referred to a collaborating medical institution's internal medicine department. In the internal medicine department, HbA1c levels are measured, and an oral glucose tolerance test is performed to diagnose diabetes or prediabetes.
Management information
Registered date
| 2025 | Year | 01 | Month | 29 | Day |
Last modified on
| 2025 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064990
