UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046088 |
|---|---|
| Receipt number | R000052609 |
| Scientific Title | A study for the usefulness of blood glycated albumin measurement by delivery |
| Date of disclosure of the study information | 2021/11/19 |
| Last modified on | 2023/11/21 08:50:48 |
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Basic information
Public title
A study for the usefulness of blood glycated albumin measurement by delivery
Acronym
A study for the usefulness of blood glycated albumin measurement by delivery
Scientific Title
A study for the usefulness of blood glycated albumin measurement by delivery
Scientific Title:Acronym
A study for the usefulness of blood glycated albumin measurement by delivery
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to verify the usefulness of blood glycated albumin measurements in delivery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
HbA1c level, glycated albumin level, fasting blood glucose level
Key secondary outcomes
body weight, waist circumference, Inbody, lipids, liver/kidney function, questionnaires
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
No blood glycated albumin measurement by delivery is taken in this group
Interventions/Control_2
blood glycated albumin measurement by delivery (every week, for 3 months) in this group
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
Men and women over 20 years old, type 2 diabetic patients with HbA1c of 6.5% or more
Key exclusion criteria
HbA1c level less than 6.5%, HIV, hepatitis B, hepatitis C, syphilis positive in infectious disease test, insulin use
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | AIHARA |
| Last name | Kubota |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Diabetes and Metabolic Diseases
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
nkubota-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | MASAKAZU |
| Middle name | |
| Last name | AIHARA |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Diabetes and Metabolic Diseases
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
maihara-tky@umin.ac.jp
Sponsor or person
Institute
Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Graduate School of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-3815-5411
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
| 2021 | Year | 11 | 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
98
Results
Results date posted
| 2023 | Year | 11 | Month | 21 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Delay for analysis
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 16 | Day |
Last modified on
| 2023 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052609
