UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031041 |
|---|---|
| Receipt number | R000035451 |
| Scientific Title | Efficacy and safety in SGLT2 inhibitor for non-diabetes complicated by non-alcoholic fatty liver disease/non-alcoholic steatohepatitis. |
| Date of disclosure of the study information | 2018/01/29 |
| Last modified on | 2019/08/03 21:31:23 |
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Basic information
Public title
Efficacy and safety in SGLT2 inhibitor for non-diabetes complicated by non-alcoholic fatty liver disease/non-alcoholic steatohepatitis.
Acronym
SGLT2 inhibitor for non-diabetes complicated by NAFLD/NASH.
Scientific Title
Efficacy and safety in SGLT2 inhibitor for non-diabetes complicated by non-alcoholic fatty liver disease/non-alcoholic steatohepatitis.
Scientific Title:Acronym
SGLT2 inhibitor for non-diabetes complicated by NAFLD/NASH.
Region
| Japan |
Condition
Condition
non-diabetes complicated by non-alcoholic fatty liver disease / non-alcoholic steatohepatitis
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy and safety in SGLT2 inhibitor for non-diabetes complicated by NAFLD/NASH.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hepatic fat content (HFC) changes of MRS are evaluated at two points of the baseline and 24 weeks after the start of treatment.
Key secondary outcomes
body weight, blood pressure, visceral fat area (VFA), subcutaneous fat area (SFA), pancreatic fat content (PFC), liver fibrosis markers, aspartate aminotransferase, alanine aminotransferase, and gamma glutamyl transpeptidase are evaluated at two points of the baseline and 24 weeks after the start of treatment.
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
The group with SGLT2 inhibitor, diet therapy and exercise therapy for 24 weeks.
Interventions/Control_2
The group with diet therapy and exercise therapy for 24 weeks.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)non-diabetes complicated by NAFLD/NASH
(2)Patients with BMI more than 22.0 kg/m2
Key exclusion criteria
(1)Choronic hepatitis such as liver cirrhosis, viral hepatitis, alcoholic hepatitis
(2)Known or suspected abuse of alcohol
(3)Treatment with steroid
(4)Patients with severe vascular disease such as stroke, myocardial infarction within the past 6 months
(5)Impaired liver function, defined as alanine aminotransferase >4 times upper limit of normal, or Child-pugh C cirrhosis
(6)Impaired renal function defined as eGFR <45ml/min
(7)Treatment with SGLT2 inhibitor or pioglitazone
(8)Pregnancy or breast feeding
(9)Cancer and other severe disease
(10)Patients with mental illness or drug addicts
(11)Patients who are difficult to perform MRI examination such as implantable defibrillators and internal metals
(12)Others judged unsuitable by researchers
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Okada |
Organization
Kobe medical university
Division name
Diabetes and Endocrinoplogy
Zip code
Address
7-5-1,Kusunoki-Cho, Chuo-Ku, Kobe
TEL
078-382-5861
yokada@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Okada |
Organization
Kobe medical university
Division name
Diabetes and Endocrinoplogy
Zip code
Address
7-5-1,Kusunoki-Cho, Chuo-Ku, Kobe
TEL
078-382-5861
Homepage URL
yokada@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe university school of medicine, Diabetes and Endocrinoplogy
Institute
Department
Personal name
Funding Source
Organization
Donation
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
Address
Tel
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
| 2018 | Year | 01 | Month | 29 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | 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
| 2018 | Year | 01 | Month | 29 | Day |
Last modified on
| 2019 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035451
