UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055471 |
|---|---|
| Receipt number | R000063116 |
| Scientific Title | The association between Fibrosis index 4 and renal dysfuction in type 2 diabetes taking SGLT2 inhibitors |
| Date of disclosure of the study information | 2024/09/15 |
| Last modified on | 2024/09/10 15:36:00 |
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Basic information
Public title
The association between Fibrosis index 4 and renal dysfuction in type 2 diabetes taking SGLT2 inhibitors
Acronym
The association between Fibrosis index 4 and renal dysfuction in type 2 diabetes taking SGLT2 inhibitors
Scientific Title
The association between Fibrosis index 4 and renal dysfuction in type 2 diabetes taking SGLT2 inhibitors
Scientific Title:Acronym
The association between Fibrosis index 4 and renal dysfuction in type 2 diabetes taking SGLT2 inhibitors
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether Fibrosis index 4 can be used as the prognosic marker for renal dysfunction in the patients with type 2 diabetes who newly start SGLT2 inhibitors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Is there any differecnces in the occurence of renal dysfunction according to the FIB-4
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
Adult type 2 diabetes patients who newry start SGLT2 inhibitors
Key exclusion criteria
nothing
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Toshihiko |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Division name
Department of Nephrology, Endocrinology and Diabetes
Zip code
2790001
Address
3-4-32, Todaijima, Urayasu city, Chiba
TEL
047-351-3101
toshi-s@xj9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Takano |
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Division name
Department of Nephrology, Endocrinology and Diabetes
Zip code
2790001
Address
3-4-32, Todaijima, Urayasu city, Chiba
TEL
047-351-3101
Homepage URL
kt900928@gmail.com
Sponsor or person
Institute
Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
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
Tokyo Bay Urayasu Ichikawa Medical Center
Address
3-4-32, Todaijima, Urayasu city, Chiba
Tel
047-351-3101
toshi-s@xj9.so-net.ne.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 | 09 | Month | 15 | 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
136
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
| 2024 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient Characteristics
Age
Sex
Fibrosis index 4
renal dysfunction
Management information
Registered date
| 2024 | Year | 09 | Month | 10 | Day |
Last modified on
| 2024 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063116
