UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of intensive insulin therapy on diabetic retinopathy and other diabetic complications
Title of the study (Brief title)	Effect of intensive insulin therapy on diabetic retinopathy and other diabetic complications
Region	Japan

Condition
Condition	diabetes mellitus
Classification by specialty	Endocrinology and Metabolism Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Main purpose of this study is that evaluation of the intensive insulin therapy effect on the retinal vascular density using optical coherence tomography (OCT) angiography.
Basic objectives2	Others
Basic objectives -Others	Second purpose of this study is that evaluation of the intensive insulin therapy effect on the diabetic complications.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate the association between retinal vascular density change and retinal vascular abnormalities using OCT angiography and the change of blood glucose level
Key secondary outcomes	Evaluation the association between retinal vascular changes using OCT angiography and diabetic microvascular complications

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. the cases of hospitalization more than 2 weeks in order to control blood glucose level 2. 20 years of age or more 3. HbA1c is more than 8.0% and less than 18.0% at the research participation
Key exclusion criteria	1. pregnant women, women of childbearing potential and lactating women 2. the subjects with severe infection or injuries 3. the subjects with pacemaker or cochlear implant 4. the subjects the principal investigator decide unfit for this study
Target sample size	150

Research contact person
Name of lead principal investigator	kotaro tsuboi
Organization	Aichi Medical University
Division name	department of ophthalmology
Address	1-1 yazako karimata nagakute aichi
TEL	0561623311
Email	tsuboi.koutarou.230@mail.aichi-med-u.ac.jp

Public contact
Name of contact person	kotaro tsuboi
Organization	Aichi Medical University
Division name	department of ophthalmology
Address	1-1 yazako karimata nagakute aichi
TEL	0561623311
Homepage URL
Email	tsuboi.koutarou.230@mail.aichi-med-u.ac.jp

Sponsor
Institute	Aichi Medical University department of ophthalmology
Institute
Department

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)

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 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 02 Month 20 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	none

Management information
Registered date	2017 Year 03 Month 03 Day
Last modified on	2018 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030314