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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046088
Receipt No. 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 2021/11/26

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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
Email 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
Email maihara-tky@umin.ac.jp

Sponsor
Institute Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo
Institute
Department

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
Email 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
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 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
2021 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052609

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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