UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061824 |
|---|---|
| Receipt number | R000070678 |
| Scientific Title | Elucidation of the Effects of Antidiabetic Drugs on the Progression of Diabetic Nephropathy via the Bacteria-Derived Peptide Corisin |
| Date of disclosure of the study information | 2026/06/08 |
| Last modified on | 2026/06/08 13:19:17 |
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Basic information
Public title
Elucidation of the Effects of Antidiabetic Drugs on the Progression of Diabetic Nephropathy via the Bacteria-Derived Peptide Corisin
Acronym
Elucidation of the Effects of Antidiabetic Drugs on the Progression of Diabetic Nephropathy via the Bacteria-Derived Peptide Corisin
Scientific Title
Elucidation of the Effects of Antidiabetic Drugs on the Progression of Diabetic Nephropathy via the Bacteria-Derived Peptide Corisin
Scientific Title:Acronym
Elucidation of the Effects of Antidiabetic Drugs on the Progression of Diabetic Nephropathy via the Bacteria-Derived Peptide Corisin
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will investigate whether administration of the target drugs (metformin, SGLT2 inhibitors, GLP-1 receptor agonists, and GLP-1/GIP receptor agonists) alters the systemic levels of the microbiota-derived peptide corisin and examine its association with parameters related to the progression of vascular complications, including diabetic nephropathy. These parameters will include clinical laboratory data obtained during routine medical care, patient background information extracted from electronic medical records, and results of corisin-related laboratory analyses performed in our research laboratory.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In this study, we will investigate whether administration of the target drugs (metformin, SGLT2 inhibitors, GLP-1 receptor agonists, and GLP-1/GIP receptor agonists) alters the systemic levels of the microbiota-derived peptide corisin and examine its association with parameters related to the progression of vascular complications, including diabetic nephropathy. These parameters will include clinical laboratory data obtained during routine medical care, patient background information extracted from electronic medical records, and results of corisin-related laboratory analyses performed in our research laboratory.
Key secondary outcomes
Effects on Glycemic Control
Effects on Lipid Profiles
Effects on Body Weight and Body Composition
Effects on Vascular Complications
Effects on Liver Function
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to receive treatment with metformin, SGLT2 inhibitors, GLP-1 receptor agonists, or GLP-1/GIP receptor agonists at Mie University Hospital.
Patients aged 20 years or older.
Patients (or their legally authorized representatives) who provide written informed consent.
Key exclusion criteria
Patients whom the principal investigator or a sub-investigator judges to be unsuitable for inclusion in the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Nishihama |
Organization
Mie University
Division name
Department of Diabetes, Metabolism, and Endocrinology
Zip code
514-8507
Address
2-174, Edobashi, Tsu-City, Mie, Japan
TEL
059-232-1111
k-nishihama@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Chisa |
| Middle name | |
| Last name | Inoue |
Organization
Mie University
Division name
Department of Diabetes, Metabolism, and Endocrinology
Zip code
514-8507
Address
2-174, Edobashi, Tsu-City, Mie, Japan
TEL
059-232-1111
Homepage URL
chisa0417@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174, Edobashi, Tsu-City, Mie
Tel
059-231-5247
kk-sien@med.mie-u.ac.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
| 2026 | Year | 06 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we will investigate whether administration of the target drugs (metformin, SGLT2 inhibitors, GLP-1 receptor agonists, and GLP-1/GIP receptor agonists) alters the systemic levels of the microbiota-derived peptide corisin and examine its association with parameters related to the progression of vascular complications, including diabetic nephropathy. These parameters will include clinical laboratory data obtained during routine medical care, patient background information extracted from electronic medical records, and results of corisin-related laboratory analyses performed in our research laboratory.
Management information
Registered date
| 2026 | Year | 06 | Month | 08 | Day |
Last modified on
| 2026 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070678
