UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018913 |
|---|---|
| Receipt number | 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 | 2020/09/09 19:36:18 |
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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 | 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
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
kakizaki@gunma-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021882
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
