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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000047695
Receipt No. 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 2022/05/09

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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
Email 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
Email kyuyong-cho@med.hokudai.ac.jp

Sponsor
Institute Sapporo Diabetes and Thyroid Clinic
Institute
Department

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
Email 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 No longer recruiting
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
2022 Year 05 Month 09 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054376

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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