UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041563 |
|---|---|
| Receipt number | R000047457 |
| Scientific Title | Research for new factors associated with diabetic complications |
| Date of disclosure of the study information | 2020/08/26 |
| Last modified on | 2020/08/26 17:41:27 |
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Basic information
Public title
Research for new factors associated with diabetic complications
Acronym
Research for new factors associated with diabetic complications
Scientific Title
Research for new factors associated with diabetic complications
Scientific Title:Acronym
Research for new factors associated with diabetic complications
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
| Endocrinology and Metabolism | Nephrology | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to search for new factors associated with diabetic complications.
Basic objectives2
Others
Basic objectives -Others
cross-sectional and retrospective study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Associations between clinical characteristics and both development and progression of diabetic complications.
Key secondary outcomes
Associations between clinical characteristics and both pathophysiology and severity of diabetic complications.
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
1. Patients treated with diabetes
2. Patients aged 20 years or older
Key exclusion criteria
1. Patients less that 20 years
2. Patients refusing the use of own clinical data
3. Patients who the principal investigator determined to be unsuitable for study
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Watanabe |
| Middle name | |
| Last name | Kentaro |
Organization
Nihon University School of Medicine
Division name
Division of Diabetes and Metabolic Diseases, Department of Internal Medicine
Zip code
1738610
Address
30-1 Oyaguchi-kamicho, Itbashi-ku
TEL
0339728111
watanabe.kentaro@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Watanabe |
| Middle name | |
| Last name | Kentaro |
Organization
Nihon University School of Medicine
Division name
Division of Diabetes and Metabolic Diseases, Department of Internal Medicine
Zip code
1738610
Address
30-1 Oyaguchi-kamicho, Itabashi-ku
TEL
0339728111
Homepage URL
watanabe.kentaro@nihon-u.ac.jp
Sponsor or person
Institute
Division of Diabetes and Metabolic Diseases, Department of Internal Medicine, Nihon University School of Medicine
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
Nihon University Itabashi Hospital Clinical Research Judging Committee
Address
30-1 Oyaguchi-kamicho, Itbashi-ku
Tel
0339728111
watanabe.kentaro@nihon-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
日本大学医学部附属板橋病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 26 | 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
| 2018 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Interim analysis is performed
Management information
Registered date
| 2020 | Year | 08 | Month | 26 | Day |
Last modified on
| 2020 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047457
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
