UMIN-CTR Clinical Trial

Basic information
Public title	Effect of high dose SGLT-2 inhibitor on fatty liver
Acronym	Effect of high dose SGLT-2 inhibitor on fatty liver
Scientific Title	Effect of high dose SGLT-2 inhibitor on fatty liver
Scientific Title:Acronym	Effect of high dose SGLT-2 inhibitor on fatty liver
Region	Japan

Condition
Condition	type2 diabetes/fatty liver
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine whether high dose SGLT-2 inhibitor improves fatty liver in diabetic patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Compare AST, ALT, FIB-4 index, and NAFLD fibrosis score (NFS) before and after treatment in patients receiving high dose SGLT-2 inhibitor for at least 6 months
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Diabetic patients whose HbA1C does not improve with regular doses of SGLT-2 inhibitor and who have started higher doses SGLT-2 inhibitor
Key exclusion criteria	Patients who have completed less than 6 months of high-dose SGLT-2 inhibitor therapy
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hironori Middle name Last name Konuma
Organization	Konuma Internal medicine Gastroenterology Clinic
Division name	directer
Zip code	329-2722
Address	6-42 Nishiasahityo,Nasushiobara city,Tochigi,Japan
TEL	0287375353
Email	hkonuma.drdr@gmail.com

Public contact
Name of contact person	1st name Hironori Middle name Last name Konuma
Organization	Konuma Internal medicine Gastroenterology Clinic
Division name	directer
Zip code	329-2722
Address	6-42 Nishiasahityo,Nasushiobara city,Tochigi,Japan
TEL	0287375353
Homepage URL
Email	hkonuma.drdr@gmail.com

Sponsor
Institute	Konuma Internal medicine Gastroenterology Clinic directer
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Konuma Internal medicine Gastroenterology Clinic
Address	6-42 Nishiasahityo,Nasushiobara city,Tochigi,Japan
Tel	0287375353
Email	hkonuma.drdr@gmail.com

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	小沼内科胃腸科クリニック（栃木県）

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 23 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	20
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	2021 Year 01 Month 04 Day
Date of IRB	2021 Year 03 Month 12 Day
Anticipated trial start date	2021 Year 01 Month 05 Day
Last follow-up date	2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2022 Year 03 Month 23 Day
Last modified on	2022 Year 03 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053896