UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055384 |
|---|---|
| Receipt number | R000063291 |
| Scientific Title | Association between the effect of luseogliflozin on liver fibrosis and alcohol consumption |
| Date of disclosure of the study information | 2024/08/31 |
| Last modified on | 2024/08/31 09:23:12 |
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Basic information
Public title
The effect of luseogliflozin on liver fibrosis differs depending on alcohol consumption in patients with type 2 diabetes
Acronym
Association between the effect of luseogliflozin on liver fibrosis and alcohol consumption
Scientific Title
Association between the effect of luseogliflozin on liver fibrosis and alcohol consumption
Scientific Title:Acronym
Association between the effect of luseogliflozin on liver fibrosis and alcohol consumption
Region
| Japan |
Condition
Condition
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
Comparison of the changes in FIB-4 after the initiation of luseogliflozin therapy between patients with type 2 diabetes with and without alcohol consumption
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FIB-4
Key secondary outcomes
HbA1c, body weight, and serum albumin concentration
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
Patients with type 2 diabetes whose drinking habits were known and who continued luseogliflozin therapy over 12 months
Key exclusion criteria
Subjects whose observation period was less than 12 months
Subjects whose drinking habits were unknown
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
133-0052
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
TEL
03-3673-1221
ito@edogawa.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
133-0052
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
TEL
03-3673-1221
Homepage URL
ito@edogawa.or.jp
Sponsor or person
Institute
Edogawa Hospital
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 of Edogawa Hospital
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
Tel
03-3673-1221
ito@edogawa.or.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
| 2024 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
192
Results
Not published
Results date posted
| 2024 | Year | 08 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
192 patients with type 2 diabetes who continued luseogliflozin therapy over 12 months and whose drinking habits were known
Participant flow
Patients with type 2 diabetes were extracted
Adverse events
Not examined
Outcome measures
FIB-4
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2024 | Year | 08 | Month | 31 | Day |
Last modified on
| 2024 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063291
