UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047552 |
|---|---|
| Receipt number | R000054227 |
| Scientific Title | Comparative study of diagnostic accuracy of glucose spikes of 1,5-AG and HbA1c in patients with impaired glucose tolerance (preliminary diabetes group) in Kagawa Prefecture |
| Date of disclosure of the study information | 2022/04/21 |
| Last modified on | 2025/04/22 10:10:55 |
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Basic information
Public title
Comparative study of diagnostic accuracy of glucose spikes of 1,5-AG and HbA1c in patients with impaired glucose tolerance (preliminary diabetes group) in Kagawa Prefecture
Acronym
Comparative study of diagnostic accuracy of glucose spikes of 1,5-AG and HbA1c in patients with impaired glucose tolerance (preliminary diabetes group) in Kagawa Prefecture
Scientific Title
Comparative study of diagnostic accuracy of glucose spikes of 1,5-AG and HbA1c in patients with impaired glucose tolerance (preliminary diabetes group) in Kagawa Prefecture
Scientific Title:Acronym
Comparative study of diagnostic accuracy of glucose spikes of 1,5-AG and HbA1c in patients with impaired glucose tolerance (preliminary diabetes group) in Kagawa Prefecture
Region
| Japan |
Condition
Condition
Impaired glucose tolerance
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1,5-AG has a higher ability to detect glucose spikes in impaired glucose tolerance than HbA1c. To test this research hypothesis, OGTT will be performed on impaired glucose tolerance patients (preliminary group for diabetes) in Kagawa Prefecture, and the diagnostic accuracy of 1,5-AG for post-load blood glucose level will be compared with HbA1c.
Basic objectives2
Others
Basic objectives -Others
We test the hypothesis that 1,5-AG has a higher ability to detect glucose spikes in impaired glucose tolerance than HbA1c.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the ROC curve (AUC) of 1,5-AG that detects a blood glucose level of 180 mg / dL 1 hour after OGTT.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients whose HbA1c value at the time of medical examination is 5.6% or more and less than 6.5%
(2)20 years old or older and under 65 years old
(3)Gender does not matter
(4)Those who have consented to this research
Key exclusion criteria
(1)Pregnant women, lactation period, women who may become pregnant
(2)Those who are being treated for type 1 or type 2 diabetes
(3)Active chronic liver disease with decreased renal function (serum creatinine 2.0 mg / dL or higher) and decreased albumin (Alb <3.0 g / dL) during anemia (Hb <10 g / dL) or anemia treatment.
(4)When the researcher judges that it is inappropriate for this research
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | toshihiro |
| Middle name | |
| Last name | kobayashi |
Organization
Kagawa University
Division name
endocrinology metabolism
Zip code
761-0793
Address
1750-1,Miki-cho, Kita-gun
TEL
0878912230
fukunaga@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | toshihiro |
| Middle name | |
| Last name | kobayashi |
Organization
Kagawa University
Division name
endocrinology metabolism
Zip code
761-0793
Address
1750-1,Miki-cho, Kita-gun
TEL
0878912230
Homepage URL
fukunaga@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
NIPPON KAYAKU
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
The Ethics Committee, faculty of medicine, kagawa university
Address
1750-1,Miki-cho, Kita-gun
Tel
0878912230
fukunaga.kensaku@kagawa-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
| 2022 | Year | 04 | Month | 21 | 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
60
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
| 2021 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
enter
Management information
Registered date
| 2022 | Year | 04 | Month | 21 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054227
