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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018913
Receipt No. R000021882
Scientific Title Effects of SGLT-2 inhibitors for the patients with non-alcoholic fatty liver disease (NAFLD) complicated with type 2 diabetes mellitus.
Date of disclosure of the study information 2015/09/04
Last modified on 2017/03/06

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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
Middle name
Last name Satoru Kakizaki
Organization Gunma University Graduate School of Medicine
Division name Department of Medicine and Molecular Science
Zip code
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
Middle name
Last name Satoru Kakizaki
Organization Gunma University Graduate School of Medicine
Division name Department of Medicine and Molecular Science
Zip code
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
Address
Tel
Email

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
2017 Year 03 Month 06 Day


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

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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