UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060548 |
|---|---|
| Receipt number | R000069231 |
| Scientific Title | An observational study on the development and progression of complications and comorbidities in Japandes patients with diabetes |
| Date of disclosure of the study information | 2026/02/09 |
| Last modified on | 2026/02/02 09:25:09 |
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Basic information
Public title
An observational study on the development and progression of complications and comorbidities in patients with diabetes
Acronym
JDPCC Study
Scientific Title
An observational study on the development and progression of complications and comorbidities in Japandes patients with diabetes
Scientific Title:Acronym
JDPCC Study
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to longitudinally observe the development and progression of diabetic complications and comorbidities in patients with diabetes and to clarify their clinical characteristics.
In addition, the study comprehensively examines the associations between the development and progression of diabetic complications and comorbidities and various clinical factors, including vascular disorders, neuropathy, nephropathy, oral health status including periodontal disease, osteoporosis, sarcopenia, laboratory parameters, lifestyle factors, nutritional status, and physical activity.
Basic objectives2
Others
Basic objectives -Others
This study is an observational study continuously conducted at a single-center diabetic complications outpatient clinic, aiming to characterize the real-world development and progression of diabetic complications and comorbidities under routine clinical practice.
The data obtained from this study are positioned as foundational evidence for understanding the long-term natural history of diabetic complications and for exploratorily identifying clinical factors associated with the development and progression of these complications.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Development and progression of diabetic complications and comorbidities
Key secondary outcomes
Vascular, neurological, renal, periodontal, osteoporosis,sarcopenia parameters, assessed in the diabetic complications outpatient clinic, including carotid ultrasonography, CAVI, ABI/TBI, neuropathy assessments, renal function tests, periodontal examinations, dual-energy X-ray Absorptiometry, and body compsition analysis by Inbody.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with diabetes
Key exclusion criteria
1. Patients who are unable to provide written informed consent for study participation
2. Patients whom the attending physician judges to be inappropriate for study participation
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Naruse |
Organization
Schoool of Dentitry, Aichi Gakuin University
Division name
Department of Internal Medicine
Zip code
464-8651
Address
2-11, Suemori-dori, Chikusa-ku, Nagoya
TEL
052-759-2111
narusek@dpc.agu.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Naruse |
Organization
School of Dentistry, Aichi Gakuin University
Division name
Department of Internal Medicine
Zip code
464-8651
Address
2-11, Suemori-dori, Chikusa-ku, Nagoya
TEL
052-759-2111
Homepage URL
narusek@dpc.agu.ac.jp
Sponsor or person
Institute
Aichi Gakuin University
Institute
Department
Personal name
Keiko Naruse
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ethic committee of School of Dentistry, Aichi Gakuin University
Address
1-100, Kusumoro-cho, Chikusa-ku, Nagoya
Tel
052-759-2111
shigaku@dpc.agu.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
愛知学院大学歯学部附属病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study that was initiated prior to registration with the UMIN Clinical Trials Registry and has been ongoing for more than ten years.
Since its initiation, the study has been conducted appropriately with approval from the institutional ethics committee.
In response to the increasing demand for transparency in clinical research, the present registration with the UMIN Clinical Trials Registry is intended to clarify the study outline and analysis plan.
The study is currently ongoing, and patient enrollment and follow-up are continuing.
The primary analyses are planned to be conducted after registration with the UMIN Clinical Trials Registry.
Management information
Registered date
| 2026 | Year | 02 | Month | 02 | Day |
Last modified on
| 2026 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069231
