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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028410
Receipt No. 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 2017/07/27

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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
Middle name
Last name Takeshi Hayashi
Organization The Jikei university school of medicine. Katsushika medical center
Division name division of diabetes metabolism and endocrinology
Zip code
Address 6-41-2 aoto, katsushika-ku, tokyo, japan
TEL 03-3603-2111
Email takeshihayashi@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Hayashi
Organization The Jikei university school of medicine. Katsushika medical center
Division name division of diabetes metabolism and endocrinology
Zip code
Address 6-41-2 aoto, katsushika-ku, tokyo, japan
TEL 03-3603-2111
Homepage URL
Email takeshihayashi@jikei.ac.jp

Sponsor
Institute The Jikei university school of medicine. Katsushika medical center
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2017 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 25 Day
Last follow-up date
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
2017 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031533

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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