UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059645 |
|---|---|
| Receipt number | R000068217 |
| Scientific Title | Effect of SGLT2 Inhibitors on Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes: A Retrospective Observational Study Using the Japan Diabetes Research and Management Database (J-DREAMS) |
| Date of disclosure of the study information | 2025/11/05 |
| Last modified on | 2025/11/05 14:23:07 |
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Basic information
Public title
Effect of SGLT2 Inhibitors on Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes: A Study Using an Medical Record Database
Acronym
Effect of SGLT2 Inhibitors on Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes: A Study Using an Medical Record Database
Scientific Title
Effect of SGLT2 Inhibitors on Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes: A Retrospective Observational Study Using the Japan Diabetes Research and Management Database (J-DREAMS)
Scientific Title:Acronym
Effect of SGLT2 Inhibitors on Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes: A Study Using a Nationwide Diabetes Database Based on Medical Records
Region
| Japan |
Condition
Condition
type 2 diabetes, Non-Alcoholic Fatty Liver Disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of SGLT2 inhibitors on non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes using a nationwide diabetes database directly linked to electronic medical records
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the Fibrosis-4 Index (FIB-4 Index) before and at 1, 2, and 3 years after administration of SGLT2 inhibitors or other antidiabetic drugs.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes who newly initiated treatment with SGLT2 inhibitors or other oral antidiabetic drugs and continued the therapy for more than three years
Key exclusion criteria
Patients treated with pioglitazone or GLP-1 receptor agonists
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hisayuki |
| Middle name | |
| Last name | Katsuyama |
Organization
National Kohnodai Medical Center
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
2728516
Address
Kohnodai 1-7-1, Ichikawa-shi, Chiba, Japan
TEL
0473723501
katsuyama.h@jihs.go.jp
Public contact
Name of contact person
| 1st name | Hisayuki |
| Middle name | |
| Last name | Katsuyama |
Organization
National Kohnodai Medical Center
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
2728516
Address
Kohnodai 1-7-1, Ichikawa-shi, Chiba, Japan
TEL
0473723501
Homepage URL
katsuyama.h@jihs.go.jp
Sponsor or person
Institute
National Institute for Health Security
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
Ethics Committee, National Institute for Health Security
Address
Toyama 1-21-1, Shinjuku-ku, Tokyo, Japan
Tel
0332027181
kenkyu-shinsa@hosp.ncgm.go.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
| 2025 | Year | 11 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a database study using the Japan Diabetes Research and Management Database (J-DREAMS), which is directly linked to electronic medical records. No patient enrollment will be conducted.
Management information
Registered date
| 2025 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068217
