UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023859 |
|---|---|
| Receipt number | R000027227 |
| Scientific Title | The relationship between ocular and systemic clinical findings in type-2 diabetes using non-invasive examinations |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2023/09/21 12:38:00 |
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Basic information
Public title
The relationship between ocular and systemic clinical findings in type-2 diabetes using non-invasive examinations
Acronym
Ocular and systemic clinical findings in type-2 diabetes
Scientific Title
The relationship between ocular and systemic clinical findings in type-2 diabetes using non-invasive examinations
Scientific Title:Acronym
Ocular and systemic clinical findings in type-2 diabetes
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the relationship between ocular and systemic clinical findings in type-2 diabetes.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Systemic and ocular clinical findings including retinal thickness and ocular blood flow in type-2 diabetes.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All subjects had type-2 diabetes with either NDR or NPDR, were aged 20-80 Y.O., and were observed at Tohoku University Hospital. The subjects underwent a baseline ophthalmic examination, including measurement of visual acuity and intraocular pressure (IOP), a slit lamp examination, and a fundus examination.
Key exclusion criteria
The exclusion criteria were the presence of pancreatic diabetes, hepatic diabetes, gestational diabetes, secondary diabetes from endocrine disease or type 1 diabetes; ongoing hemodialysis; current malignant, inflammatory disease or chronic respiratory disease; age-related macular degeneration; glaucoma; and retinal diseases other than NPDR.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | HIDEKI |
| Middle name | |
| Last name | KATAGIRI |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Metabolism and Diabetes
Zip code
980-8574
Address
Tohoku University Graduate School of Medicine, Department of Ophthalmology, 1-1 Seiryo, Aoba, Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7611
hisyo@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | SHOJIRO |
| Middle name | |
| Last name | SAWADA |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Metabolism and Diabetes
Zip code
980-8574
Address
Tohoku University Graduate School of Medicine, Department of Ophthalmology, 1-1 Seiryo, Aoba, Sendai
TEL
022-717-7611
Homepage URL
ssawada@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine
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
Tohoku University Graduate School of Medicine
Address
Tohoku University Graduate School of Medicine, Department of Ophthalmology, 1-1 Seiryo, Aoba, Sendai
Tel
022-717-7611
myasuda@oph.med.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Date of protocol fixation
| 2013 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | 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
Observation examination
Management information
Registered date
| 2016 | Year | 08 | Month | 31 | Day |
Last modified on
| 2023 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027227
