UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019155 |
|---|---|
| Receipt number | R000022148 |
| Scientific Title | Association diabetic complications and finger autofluorescence |
| Date of disclosure of the study information | 2015/09/30 |
| Last modified on | 2025/10/06 09:34:06 |
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Basic information
Public title
Association diabetic complications and finger autofluorescence
Acronym
Finger autofluorescence in diabetes
Scientific Title
Association diabetic complications and finger autofluorescence
Scientific Title:Acronym
Finger autofluorescence in diabetes
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether skin autofluorescene is associated with severity and prognosis of diabetic complications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Newly onset of diabetic complications
Key secondary outcomes
Worsening diabetic complications ,Total mortality
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 with diabetes,IGT,NGT
Key exclusion criteria
none
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Ogawa |
| Middle name | |
| Last name | Osamu |
Organization
Kameda Medical Center
Division name
Department of Diabetes and Endocrinology
Zip code
296-8602
Address
929 Higashi-cho Kamogawa City
TEL
04-7092-2211
ogawa.osamu@kameda.jp
Public contact
Name of contact person
| 1st name | Ogawa |
| Middle name | |
| Last name | Osamu |
Organization
Kameda Medical Center
Division name
Department of Diabetes and Endocrinology
Zip code
296-8602
Address
929 Higashi-cho Kamogawa City
TEL
04-7092-2211
Homepage URL
ogawa.osamu@kameda.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kameda Medical Center
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
Kameda Medical Center
Address
929 Higashi-cho Kamogawa City
Tel
04-7092-2211
rinri@kameda.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
| 2015 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000022148
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/tonyobyo/68/Suppl/68_S-295/_article/-char/ja/
Number of participants that the trial has enrolled
345
Results
An association was observed between cardiovascular events and finger autofluorescence.
Results date posted
| 2025 | Year | 10 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Type 1 diabetes 22, Type 2 diabetes 318, other 5
Participant flow
Outpatients receiving treatment at the Department of Diabetes and Endocrinology Kameda medical center who provided informed consent to participate in the study
Adverse events
N/A
Outcome measures
diabetes related complications
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2015 | Year | 09 | Month | 29 | Day |
Last modified on
| 2025 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022148
