UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047695 |
|---|---|
| Receipt number | R000054376 |
| Scientific Title | The change of urine L-FABP for patients with SGLT2 inhibitor with type 2 diabetes |
| Date of disclosure of the study information | 2022/05/09 |
| Last modified on | 2023/07/24 17:34:23 |
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Basic information
Public title
The change of urine L-FABP for patients with SGLT2 inhibitor with type 2 diabetes
Acronym
Urine L-FABP with SGLT2 inhibitor
Scientific Title
The change of urine L-FABP for patients with SGLT2 inhibitor with type 2 diabetes
Scientific Title:Acronym
Urine L-FABP with SGLT2 inhibitor
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim to observe the urine L-FABP change and the relationship with other parameters after administration of SGLT2 inhibitors in type 2 diabetic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
The urine L-FABP change with SGLT2 inhibitors in type 2 diabetic patients.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients with type 2 diabetes for 1st April 2013 to 30th April 2020, and including follows:
1.those who was with multiple sampling of urine L-FABP
2.20 years old and more
3.those who was the administration of SGLT2 inhibitors
4.those who do not refuse to participate in this research
Key exclusion criteria
1.those who had serious liver or kidney diseases.
2.those who was with diabetic ketosis, coma, or pre-coma.
3.those who had infection, peri-operation, operation, or trauma.
4.those who was with pregnancy
5.those who was judged inappropriate as participants.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Chiho |
| Middle name | |
| Last name | Oba-Yamamoto |
Organization
Sapporo Diabetes and Thyroid Clinic
Division name
Internal medicine
Zip code
060-0807
Address
2F, Sapporo Kita Building, 8-1, Kita7-jou Nishi 2-chome,Kita-ku, Sapporo
TEL
011-707-1024
yamamoto_chiho_o@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kyu Yong |
| Middle name | |
| Last name | Cho |
Organization
Hokkaido University Hospital
Division name
Institute of Health Science Innovation for Medical Care
Zip code
060-8648
Address
N14W5, kita-ku, Sapporo, Hokkaido
TEL
011-706-7061
Homepage URL
kyuyong-cho@med.hokudai.ac.jp
Sponsor or person
Institute
Sapporo Diabetes and Thyroid Clinic
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
Ethics committee, Sapporo Diabetes and Thyroid Clinic
Address
2F, Sapporo Kita Building, 8-1, Kita7-jou Nishi 2-chome,Kita-ku, Sapporo
Tel
011-707-1024
jun_takeuchi@me.com
Secondary IDs
Secondary IDs
YES
Study ID_1
022-001
Org. issuing International ID_1
Sapporo Diabetes and Thyroid Clinic
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 | 05 | Month | 09 | 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
124
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
| 2022 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective cohort study
Management information
Registered date
| 2022 | Year | 05 | Month | 09 | Day |
Last modified on
| 2023 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054376
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
