UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059867 |
|---|---|
| Receipt number | R000068460 |
| Scientific Title | Diabetic peripheral neuropathy as an independent predictor of renal function decline in type 2 diabetes: a propensity score-matched retrospective cohort study using DPN-Check |
| Date of disclosure of the study information | 2025/11/24 |
| Last modified on | 2025/11/24 11:32:25 |
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Basic information
Public title
Diabetic peripheral neuropathy as an independent predictor of renal function decline in type 2 diabetes: a propensity score-matched retrospective cohort study using DPN-Check
Acronym
Diabetic peripheral neuropathy as an independent predictor of renal function decline in type 2 diabetes: a propensity score-matched retrospective cohort study using DPN-Check
Scientific Title
Diabetic peripheral neuropathy as an independent predictor of renal function decline in type 2 diabetes: a propensity score-matched retrospective cohort study using DPN-Check
Scientific Title:Acronym
Diabetic peripheral neuropathy as an independent predictor of renal function decline in type 2 diabetes: a propensity score-matched retrospective cohort study using DPN-Check
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of diabetic peripheral neuropathy on subsequent changes in renal function in patients with type 2 diabetes.
Basic objectives2
Others
Basic objectives -Others
To evaluate the incidence of renal events
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of renal events, defined as a >30% decline in eGFR from baseline, initiation of renal replacement therapy, or death due to renal or cardiovascular disease.
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
Japanese patients with type 2 diabetes who did not have foot ulcers and underwent nerve conduction assessment using DPN-Check between June 2015 and April 2017.
Key exclusion criteria
Patients who were transferred to another medical institution or discontinued treatment within 5 years of the start of observation, and those who died due to unknown causes or unrelated to kidney disease
Target sample size
400
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
+81-3-3673-1221
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
+81-3-3673-1221
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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Edogawa Hospital
Address
2-24-18, Higashikoiwa, Edogawa-Ku, Tokyo
Tel
+81-3-3673-1221
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
| 2025 | Year | 11 | Month | 24 | 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
323
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
| 2025 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2025 | Year | 11 | Month | 24 | Day |
Last modified on
| 2025 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068460
