UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047270 |
|---|---|
| Receipt number | R000053896 |
| Scientific Title | Effect of high dose SGLT-2 inhibitor on fatty liver |
| Date of disclosure of the study information | 2022/03/23 |
| Last modified on | 2022/03/23 18:29:59 |
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Basic information
Public title
Effect of high dose SGLT-2 inhibitor on fatty liver
Acronym
Effect of high dose SGLT-2 inhibitor on fatty liver
Scientific Title
Effect of high dose SGLT-2 inhibitor on fatty liver
Scientific Title:Acronym
Effect of high dose SGLT-2 inhibitor on fatty liver
Region
| Japan |
Condition
Condition
type2 diabetes/fatty liver
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether high dose SGLT-2 inhibitor improves fatty liver in diabetic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Compare AST, ALT, FIB-4 index, and NAFLD fibrosis score (NFS) before and after treatment in patients receiving high dose SGLT-2 inhibitor for at least 6 months
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diabetic patients whose HbA1C does not improve with regular doses of SGLT-2 inhibitor and who have started higher doses SGLT-2 inhibitor
Key exclusion criteria
Patients who have completed less than 6 months of high-dose SGLT-2 inhibitor therapy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hironori |
| Middle name | |
| Last name | Konuma |
Organization
Konuma Internal medicine Gastroenterology Clinic
Division name
directer
Zip code
329-2722
Address
6-42 Nishiasahityo,Nasushiobara city,Tochigi,Japan
TEL
0287375353
hkonuma.drdr@gmail.com
Public contact
Name of contact person
| 1st name | Hironori |
| Middle name | |
| Last name | Konuma |
Organization
Konuma Internal medicine Gastroenterology Clinic
Division name
directer
Zip code
329-2722
Address
6-42 Nishiasahityo,Nasushiobara city,Tochigi,Japan
TEL
0287375353
Homepage URL
hkonuma.drdr@gmail.com
Sponsor or person
Institute
Konuma Internal medicine Gastroenterology Clinic
directer
Institute
Department
Personal name
Funding Source
Organization
none
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
Konuma Internal medicine Gastroenterology Clinic
Address
6-42 Nishiasahityo,Nasushiobara city,Tochigi,Japan
Tel
0287375353
hkonuma.drdr@gmail.com
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
小沼内科胃腸科クリニック（栃木県）
Other administrative information
Date of disclosure of the study information
| 2022 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 03 | Month | 23 | Day |
Last modified on
| 2022 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053896
