UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042492 |
|---|---|
| Receipt number | R000048506 |
| Scientific Title | To investigate the relationships between diabetic test scores and HbA1c levels in a cross-sectional study. |
| Date of disclosure of the study information | 2020/11/19 |
| Last modified on | 2021/07/05 00:26:01 |
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Basic information
Public title
To investigate the relationships between diabetic test scores and HbA1c levels in a cross-sectional study.
Acronym
To investigate the relationships between diabetic test scores and HbA1c levels in a cross-sectional study.
Scientific Title
To investigate the relationships between diabetic test scores and HbA1c levels in a cross-sectional study.
Scientific Title:Acronym
To investigate the relationships between diabetic test scores and HbA1c levels in a cross-sectional study.
Region
| Japan |
Condition
Condition
Type2diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationships between diabetic test scores and HbA1c levels in a cross-sectional study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the relationships between diabetic test scores and HbA1c levels in a cross-sectional study.
Key secondary outcomes
To investigate the relationships between diabetic test scores and BMI in a cross-sectional study.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes
Key exclusion criteria
Dementia , diabetic ketoacidosis, depression, stroke, steroid user, and the patients considered to be inappropriate for this study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Minami |
Organization
Saiseikai Yokohama Nanbu Hospital
Division name
Diabetes and Endocrinology
Zip code
234-8503
Address
3-2-10,Konandai Konan-ku,Yokohama City,Kanagawa 234-0054,Japan
TEL
045-832-1111
ksqdd034@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mayuko |
| Middle name | |
| Last name | Takahashi |
Organization
Saiseikai Yokohama Nanbu Hospital
Division name
Diabetes and Endocrinology
Zip code
234-8503
Address
3-2-10,Konandai Konan-ku,Yokohama City,Kanagawa 234-0054,Japan
TEL
045-832-1111
Homepage URL
kanagawa0320@gmail.com
Sponsor or person
Institute
Saiseikai Yokohama Nanbu Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Yokohama Nanbu Hospital
Address
3-2-10,Konandai Konan-ku,Yokohama City,Kanagawa 234-0054,Japan
Tel
0458321111
soumu01@nanbu.saiseikai.or.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
| 2020 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a cross sectional study to investigate the relationships between diabetic test scores and HbA1c levels.
The diabeteic test is on the web;http://www.city.odawara.kanagawa.jp/global-image/units/358806/1-20180807183200.pdf
Management information
Registered date
| 2020 | Year | 11 | Month | 18 | Day |
Last modified on
| 2021 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048506
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
