UMIN-CTR Clinical Trial

Basic information
Public title	Effects of SGLT-2 inhibitors for the patients with non-alcoholic fatty liver disease (NAFLD) complicated with type 2 diabetes mellitus.
Acronym	SGLT-2 and NAFLD/T2DM
Scientific Title	Effects of SGLT-2 inhibitors for the patients with non-alcoholic fatty liver disease (NAFLD) complicated with type 2 diabetes mellitus.
Scientific Title:Acronym	SGLT-2 and NAFLD/T2DM
Region	Japan

Condition
Condition	Non-alcoholic fatty liver disease (NAFLD) complicated with type 2 diabetes mellitus.
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of SGLT-2 inhibitors for the patients with non-alcoholic fatty liver disease (NAFLD) complicated with type 2 diabetes mellitus.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	GGT
Key secondary outcomes	HbA1c, Body weight, HOMA-IR

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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Uncontrolled Type 2 DM patients after 3 months of diet/exercise therapy 2) Diagnosed as fatty liver 3) BMI >/= 25kg/m2 4) GGT >/= 1.5 x normal limits 5) Need for SGLT-2 inhibitors administration 6) HbA1c >/= 6.5%
Key exclusion criteria	1) History of allergy to SGLT-2 inhibitors 2) HB/HC/autoimmune hepatitis 3) Pregnancy or lactation in women 4) Under insulin treatment 5) Excess alcohol consumption male; >/= 30g/day female; >/= 20g/day 6) Inadequacy for this therapy
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Satoru Middle name Last name Kakizaki
Organization	Gunma University Graduate School of Medicine
Division name	Department of Medicine and Molecular Science
Zip code	3718511
Address	3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL	027-220-8127
Email	kakizaki@gunma-u.ac.jp

Public contact
Name of contact person	1st name Satoru Middle name Last name Kakizaki
Organization	Gunma University Graduate School of Medicine
Division name	Department of Medicine and Molecular Science
Zip code	3718511
Address	3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL	027-220-8127
Homepage URL
Email	kakizaki@gunma-u.ac.jp

Sponsor
Institute	Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Affiliated Hospitals to Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Department of Clinical Research, Gunma University
Address	3-39-15 Showa-machi, Maebashi, Gunma, Japan
Tel	027-220-8740
Email	gunmaciru-office@umin.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	1348
Org. issuing International ID_1	Gunma University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	群馬大学附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 04 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	Open public recruiting
Date of protocol fixation	2015 Year 09 Month 02 Day
Date of IRB
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2016 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Cohort Study Recruitment of Subject From October/2015 to March/2016, The patients meet the inclusion/exclusion criteria.

Management information
Registered date	2015 Year 09 Month 04 Day
Last modified on	2020 Year 09 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021882