UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054352 |
|---|---|
| Receipt number | R000062062 |
| Scientific Title | Effect of Oral Administration of Omega-3 Fatty Acids on Retinal Neuro Function and Morphology in Diabetic Patients |
| Date of disclosure of the study information | 2024/05/09 |
| Last modified on | 2025/11/10 20:35:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of Oral Administration of Omega-3 Fatty Acids on Retinal Neuro Function and Morphology in Diabetic Patients
Acronym
Oral administration of omega-3 Fatty Acids on diabetic retinal neuropathy
Scientific Title
Effect of Oral Administration of Omega-3 Fatty Acids on Retinal Neuro Function and Morphology in Diabetic Patients
Scientific Title:Acronym
Oral Administration of omega-3 Fatty Acids on diabetic retinal neuropathy
Region
| Japan |
Condition
Condition
Diabetic retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the possibility of improving diabetic retinal neuropathy with Epadel and Lotriga, insurance-listed drugs for hyperlipidemia, which are metabolized into omega-3 fatty acids after oral administration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
inner retinal thickness
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with diabetic retinopathy severity of NDR or mild NPDR between June 1, 2024 and June 30, 2029 at the Department of Ophthalmology,Nagoya University Hospital
Key exclusion criteria
Patients with a history of the following: macular disease (retinal artery occlusion, retinal vein occlusion, age-related macular degeneration and its precursor lesions, macular edema, vitreoretinal interface abnormalities), grade 3 or higher on the Emery-Little classification cataracts or opacitas corporis vitrei that interfere with imaging studies, high myopia
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ayana |
| Middle name | |
| Last name | Suzumura |
Organization
Nagoya University Hospital
Division name
Department of Ophthalmology
Zip code
466-8550
Address
65, Tsurumai-Cho, Syowa-ku, Nagoya, Aichi
TEL
+81-52-744-2277
a.suzumura@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayana |
| Middle name | |
| Last name | Suzumura |
Organization
Nagoya University Hospital
Division name
Department of Ophthalmology
Zip code
466-8550
Address
65, Tsurumai-Cho, Syowa-ku, Nagoya, Aichi
TEL
+81-52-744-2277
Homepage URL
a.suzumura@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
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
Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
+81-52-744-2275
ethics@med.nagoya-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 09 | 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
| 2024 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2029 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2029 | Year | 09 | Month | 30 | Day |
Other
Other related information
From June 2024 to June 2029, all patients who visit the Department of Ophthalmology at Nagoya University Hospital and met the selection criteria will be enrolled in this study. We will measure best-corrected visual acuity, retinal thickness, retinal sensitivity, and other parameters to investigate the effects of oral administration of omega-3 fatty acids on retinal neural function and morphology in patients with diabetes.
Management information
Registered date
| 2024 | Year | 05 | Month | 09 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062062
