UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026379 |
|---|---|
| Receipt number | R000030314 |
| Scientific Title | Effect of intensive insulin therapy on diabetic retinopathy and other diabetic complications |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2018/09/03 09:40:51 |
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Basic information
Public title
Effect of intensive insulin therapy on diabetic retinopathy and other diabetic complications
Acronym
Effect of intensive insulin therapy on diabetic retinopathy and other diabetic complications
Scientific Title
Effect of intensive insulin therapy on diabetic retinopathy and other diabetic complications
Scientific Title:Acronym
Effect of intensive insulin therapy on diabetic retinopathy and other diabetic complications
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Main purpose of this study is that evaluation of the intensive insulin therapy effect on the retinal vascular density using optical coherence tomography (OCT) angiography.
Basic objectives2
Others
Basic objectives -Others
Second purpose of this study is that evaluation of the intensive insulin therapy effect on the diabetic complications.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the association between retinal vascular density change and retinal vascular abnormalities using OCT angiography and the change of blood glucose level
Key secondary outcomes
Evaluation the association between retinal vascular changes using OCT angiography and diabetic microvascular 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. the cases of hospitalization more than 2 weeks in order to control blood glucose level
2. 20 years of age or more
3. HbA1c is more than 8.0% and less than 18.0% at the research participation
Key exclusion criteria
1. pregnant women, women of childbearing potential and lactating women
2. the subjects with severe infection or injuries
3. the subjects with pacemaker or cochlear implant
4. the subjects the principal investigator decide unfit for this study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kotaro tsuboi |
Organization
Aichi Medical University
Division name
department of ophthalmology
Zip code
Address
1-1 yazako karimata nagakute aichi
TEL
0561623311
tsuboi.koutarou.230@mail.aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kotaro tsuboi |
Organization
Aichi Medical University
Division name
department of ophthalmology
Zip code
Address
1-1 yazako karimata nagakute aichi
TEL
0561623311
Homepage URL
tsuboi.koutarou.230@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University department of ophthalmology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 04 | Month | 01 | 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
| 2017 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 03 | Month | 03 | Day |
Last modified on
| 2018 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030314
