UMIN-CTR Clinical Trial

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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