UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026057 |
|---|---|
| Receipt number | R000029007 |
| Scientific Title | Efficacy of SGLT2 inhibitor for nonalcoholic fatty liver disease: a randomized controlled trial |
| Date of disclosure of the study information | 2017/03/23 |
| Last modified on | 2024/10/16 10:51:19 |
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Basic information
Public title
Efficacy of SGLT2 inhibitor for nonalcoholic fatty liver disease: a randomized controlled trial
Acronym
Efficacy of SGLT2 inhibitor for NAFLD
Scientific Title
Efficacy of SGLT2 inhibitor for nonalcoholic fatty liver disease: a randomized controlled trial
Scientific Title:Acronym
Efficacy of SGLT2 inhibitor for NAFLD
Region
| Japan |
Condition
Condition
Nonalcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we evaluate the efficacy and safety of SGLT2 inhibitor for nonalcoholic fatty liver disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
liver function and steatosis after 24 months
Key secondary outcomes
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
SGLT2 inhibitor group
Interventions/Control_2
normal diet group
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
NAFLD patients with type 2 diabetes
Key exclusion criteria
other chronic hepatitis patients
alcoholic hepatitis
patients with hepatocellular carcinoma
type 1 diabetes
BMI under 20
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | eiji |
| Middle name | |
| Last name | kakazu |
Organization
Tohoku university hospital
Division name
Gastroenterology
Zip code
9808574
Address
1-1 Seiryo, Aobaku, Sendai
TEL
022-717-7171
kakazu@coral.ocn.ne.jp
Public contact
Name of contact person
| 1st name | eiji |
| Middle name | |
| Last name | kakazu |
Organization
Tohoku university hospital
Division name
Gastroenterology
Zip code
9808574
Address
1-1 Seiryo, Aobaku, Sendai
TEL
022-717-7171
Homepage URL
kakazu@coral.ocn.ne.jp
Sponsor or person
Institute
Tohoku university
Institute
Department
Personal name
Funding Source
Organization
Tohoku university
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
Clinical Research, Innovation and Education Center, Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
Tel
0227177122
office@crieto.hosp.tohoku.ac.jp
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
| 2017 | Year | 03 | Month | 23 | 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
10
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
Terminated
Date of protocol fixation
| 2017 | Year | 02 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2017 | Year | 02 | Month | 08 | Day |
Last modified on
| 2024 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029007
