UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038668 |
|---|---|
| Receipt number | R000044071 |
| Scientific Title | Impact of lipid metabolism in retinal pathogenesis |
| Date of disclosure of the study information | 2019/11/24 |
| Last modified on | 2019/11/24 14:39:02 |
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Basic information
Public title
Impact of lipid metabolism in retinal pathogenesis
Acronym
Impact of lipid metabolism in retinal pathogenesis
Scientific Title
Impact of lipid metabolism in retinal pathogenesis
Scientific Title:Acronym
Impact of lipid metabolism in retinal pathogenesis
Region
| Japan |
Condition
Condition
Age-related macular degeneration, diabetic retinopathy, metabolic syndrome
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the retinal pathogenesis
Basic objectives2
Others
Basic objectives -Others
To analyze dietary information, ophthalmological findings, lipids, inflammatory and oxidative stress-related molecules, and lutein in the serum and macrophages, in the control subjects who do not have eye diseases except for cataract and refractory errors, and patients with age-related macular disease, diabetic retinopathy, and metabolic syndrome.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
dietary information, ophthalmological findings, lipids, inflammatory and oxidative stress-related molecules, and lutein in the serum and macrophages
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Control subjects who have no retinal diseases except for cataract and refractive errors, patients with age-related macular degeneration, diabetic retinopathy, and metabolic syndrome (including those who have precursor lesions)
Key exclusion criteria
Those who do not understand the research.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Ozawa |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
1608582
Address
35 Shinanomachi, Shinjukuku, Tokyo
TEL
03-3353-1211
ozawa@a5.keio.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Ozawa |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
1608582
Address
35 Shinanomachi, Shinjukuku, Tokyo
TEL
03-3353-1211
Homepage URL
ozawa@a5.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Donation
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
Keio University, School of Medicine
Address
35 Shinanomachi, Shinjukuku, Tokyo
Tel
03-3353-1211
ozawa@a5.keio.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
| 2019 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
https://www.ctr.med.keio.ac.jp/rinri/
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
Preinitiation
Date of protocol fixation
| 2019 | Year | 10 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To analyze dietary information, ophthalmological findings, lipids, inflammatory and oxidative stress-related molecules, and lutein in the serum and macrophages, in the control subjects who do not have eye diseases except for cataract and refractory errors, and patients with age-related macular disease, diabetic retinopathy, and metabolic syndrome.
Management information
Registered date
| 2019 | Year | 11 | Month | 24 | Day |
Last modified on
| 2019 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044071
| 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 |
