UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety in SGLT2 inhibitor for non-diabetes complicated by non-alcoholic fatty liver disease/non-alcoholic steatohepatitis.
Acronym	SGLT2 inhibitor for non-diabetes complicated by NAFLD/NASH.
Scientific Title	Efficacy and safety in SGLT2 inhibitor for non-diabetes complicated by non-alcoholic fatty liver disease/non-alcoholic steatohepatitis.
Scientific Title:Acronym	SGLT2 inhibitor for non-diabetes complicated by NAFLD/NASH.
Region	Japan

Condition
Condition	non-diabetes complicated by non-alcoholic fatty liver disease / non-alcoholic steatohepatitis
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the efficacy and safety in SGLT2 inhibitor for non-diabetes complicated by NAFLD/NASH.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	hepatic fat content (HFC) changes of MRS are evaluated at two points of the baseline and 24 weeks after the start of treatment.
Key secondary outcomes	body weight, blood pressure, visceral fat area (VFA), subcutaneous fat area (SFA), pancreatic fat content (PFC), liver fibrosis markers, aspartate aminotransferase, alanine aminotransferase, and gamma glutamyl transpeptidase are evaluated at two points of the baseline and 24 weeks after the start of treatment.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The group with SGLT2 inhibitor, diet therapy and exercise therapy for 24 weeks.
Interventions/Control_2	The group with diet therapy and exercise therapy for 24 weeks.
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	(1)non-diabetes complicated by NAFLD/NASH (2)Patients with BMI more than 22.0 kg/m2
Key exclusion criteria	(1)Choronic hepatitis such as liver cirrhosis, viral hepatitis, alcoholic hepatitis (2)Known or suspected abuse of alcohol (3)Treatment with steroid (4)Patients with severe vascular disease such as stroke, myocardial infarction within the past 6 months (5)Impaired liver function, defined as alanine aminotransferase >4 times upper limit of normal, or Child-pugh C cirrhosis (6)Impaired renal function defined as eGFR <45ml/min (7)Treatment with SGLT2 inhibitor or pioglitazone (8)Pregnancy or breast feeding (9)Cancer and other severe disease (10)Patients with mental illness or drug addicts (11)Patients who are difficult to perform MRI examination such as implantable defibrillators and internal metals (12)Others judged unsuitable by researchers
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuko Okada
Organization	Kobe medical university
Division name	Diabetes and Endocrinoplogy
Zip code
Address	7-5-1,Kusunoki-Cho, Chuo-Ku, Kobe
TEL	078-382-5861
Email	yokada@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yuko Okada
Organization	Kobe medical university
Division name	Diabetes and Endocrinoplogy
Zip code
Address	7-5-1,Kusunoki-Cho, Chuo-Ku, Kobe
TEL	078-382-5861
Homepage URL
Email	yokada@med.kobe-u.ac.jp

Sponsor
Institute	Kobe university school of medicine, Diabetes and Endocrinoplogy
Institute
Department

Funding Source
Organization	Donation
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
Address
Tel
Email

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	2018 Year 01 Month 29 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	Completed
Date of protocol fixation	2018 Year 01 Month 29 Day
Date of IRB	2018 Year 03 Month 22 Day
Anticipated trial start date	2019 Year 01 Month 01 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 29 Day
Last modified on	2019 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035451