UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028410 |
|---|---|
| Receipt number | R000031533 |
| Scientific Title | Study of various clinical parameters and retinal thickness by optical coherence tomography (OCT) in patients with diabetes mellitus. |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2020/08/03 22:51:42 |
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Basic information
Public title
Study of various clinical parameters and retinal thickness by optical coherence tomography (OCT) in patients with diabetes mellitus.
Acronym
Retinal Thickness and Clinical Parameters
Scientific Title
Study of various clinical parameters and retinal thickness by optical coherence tomography (OCT) in patients with diabetes mellitus.
Scientific Title:Acronym
Retinal Thickness and Clinical Parameters
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to evaluate the pathology of diabetic macular edema in diabetic patients and establish a novel treatment method, evaluation of blood sugar control status, evaluation of retinal edema by optical coherence tomography (OCT), evaluation of retinal blood flow by OCT angiography, plasma aldosterone concentration And other biochemical parameters are evaluated as main evaluation items.
Basic objectives2
Others
Basic objectives -Others
association
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Retinal change due to OCT by glycemic control an plasma aldosterone concentration.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Blood sampling at discharge
Optical coherence tomography at hospitalization and discharge
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
Type 2 diabetic patients who were hospitalized during the study period.
Key exclusion criteria
Patients with have undergone laser photocoagulation.
Cataracts in progress.
Minors.
Those who are difficult to determine consciousness by themselves, such as consciousness disorder or dementia.
Those in steroid treatment.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Hayashi |
Organization
The Jikei university school of medicine. Katsushika medical center
Division name
division of diabetes metabolism and endocrinology
Zip code
105-8471
Address
6-41-2 aoto, katsushika-ku, tokyo, japan
TEL
03-3603-2111
takeshihayashi@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Hayashi |
Organization
The Jikei university school of medicine. Katsushika medical center
Division name
division of diabetes metabolism and endocrinology
Zip code
125-8506
Address
6-41-2 aoto, katsushika-ku, tokyo, japan
TEL
03-3603-2111
Homepage URL
takeshihayashi@jikei.ac.jp
Sponsor or person
Institute
The Jikei university school of medicine. Katsushika medical center
Institute
Department
Personal name
Funding Source
Organization
The Jikei university school of medicine. Katsushika medical center
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
The Jikei university school of medicine.
Address
6-41-2 aoto, katsushika-ku, tokyo, japan
Tel
03-3603-2111
takeshihayashi@jikei.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
| 2017 | Year | 08 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 27 | Day |
Last modified on
| 2020 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031533
