UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000917 |
|---|---|
| Receipt number | R000001051 |
| Scientific Title | Circulatory parameters in the retrobulbar central retinal artery and vein of patients with diabetes and medically treated systemic hypertension |
| Date of disclosure of the study information | 2007/12/05 |
| Last modified on | 2007/12/01 11:39:26 |
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Basic information
Public title
Circulatory parameters in the retrobulbar central retinal artery and vein of patients with diabetes and medically treated systemic hypertension
Acronym
Circulatory parameters in the retinal vessels with DM and hypertension
Scientific Title
Circulatory parameters in the retrobulbar central retinal artery and vein of patients with diabetes and medically treated systemic hypertension
Scientific Title:Acronym
Circulatory parameters in the retinal vessels with DM and hypertension
Region
| Japan |
Condition
Condition
DM and Hypertension
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the circulatory parameters in the retinal cessels patients with DM & HT.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Resitiviy Index in patients with DM & HT
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diabetic patients
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kato Satoshi |
Organization
The University of Tokyo Hospital
Division name
Department of Ophthalmology
Zip code
Address
Hongo 7-3-1 Bunkyo-ku
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokyo Hospital
Division name
Department of Ophthalmology
Zip code
Address
TEL
03-3815-5411
Homepage URL
Sponsor or person
Institute
The Department of Ophthalmology
University of Tokyo 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
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
| 2007 | Year | 12 | Month | 05 | 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
Completed
Date of protocol fixation
| 2000 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2002 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2005 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 04 | Month | 01 | Day |
Other
Other related information
Cross-Section study was done.
Management information
Registered date
| 2007 | Year | 12 | Month | 01 | Day |
Last modified on
| 2007 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001051
| 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 |
