UMIN-CTR Clinical Trial

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
Email	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
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	The Jikei university school of medicine.
Address	6-41-2 aoto, katsushika-ku, tokyo, japan
Tel	03-3603-2111
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031533