UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of SGLT-2 inhibitors on Hepatic Steatosis and Fibrosis Estimated by using Fibroscan with Type 2 Diabetes Suffering from Non-alcoholic Fatty Liver Disease
Title of the study (Brief title)	STHENIC trial
Region	Japan

Condition
Condition	Type 2 Diabetes Suffering from Non-alcoholic Fatty Liver Disease
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of SGLT-2 inhibitors on hepatic steatosis and fibrosis estimated by fibroscan, visceral fat area measured, Body composition and endothelial function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of hepatic steatosis between SGLT-2 inhibitors group(Additional treatment with SGLT-2 inhibitor) and control group (aggressive conventional treatment without SGLT-2 inhibitors) at 24 weeks after starting this trial.
Key secondary outcomes	The change of visceral fat area The change of body composition The change of endothelial function The change of NAFLD fibrosis score,NAFIC score,FIB-4index and M2BPGi The change of oxidative,apoptosis markers and inflammatory cytokines. These changes will be evaluated at base line, 24 weeks between two groups

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	Additional treatment with SGLT-2 inhibitor (SGLT-2 inhibitor group) for 24 weeks administration.
Interventions/Control_2	Aggressive conventional treatment (control). (Excluding treatment with SGLT-2inhibitor and increase a dose of metformin,pioglitazone and GLP-1 receptor agonist)
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	1. Type 2 diabetes patients 2. Diagnosed fatty liver by sonography 3. Oral administration of metformin 4. Satisfying diagnostic criteria of NAFLD Patients were prospectively assigned to either additional treatment with SGLT-2 inhibitors(n=30) or aggressive conventional treatment (control, n=30) for 6 months.
Key exclusion criteria	1) Type 1 diabetes 2) Severe diabetic complications such as ketoacidosis 3) Severe renal dysfunction(estimated glomerular filtration rate [eGFR] < 30 mL/min/) 4) Pregnant or nursing women and those who might be pregnant 5) Chronic heart failure, 6) Haemodialysis, 7) A history of stroke and cardiovascular events, 8) Any patient whom the investigator judged to be inappropriate for this study. Patients were given detailed explanations of the study protocol.
Target sample size	60

Research contact person
Name of lead principal investigator	Yoshimasa Aso
Organization	Dokkyo Medical University
Division name	Endocrinology and Metabolism
Address	880, Kitakobayashi, Mibu, Shimotsugagun, Tochigi
TEL	0282-87-2150
Email	yaso@dokkyomed.ac.jp

Public contact
Name of contact person	Kunihiro Suzuki
Organization	Dokkyo Medical University
Division name	Endocrinology and Metabolism
Address	880, Kitakobayashi, Mibu, Shimotsugagun, Tochigi
TEL	0282-87-2150
Homepage URL
Email	kuni-s@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

Funding Source
Organization	Dokkyo Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2016 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 12 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 09 Month 30 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 30 Day
Last modified on	2018 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025530