UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association between Total Serum Bilirubin, Heme oxygenase-1, and Urinary Biopyrrins levels and Diabetic retinopathy
Title of the study (Brief title)	Association between Total Serum Bilirubin, Heme oxygenase-1, and Urinary Biopyrrins levels and Diabetic retinopathy
Region	Japan

Condition
Condition	Diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the association between total serum Heme oxygenase-1, bilirubin, and Urinary Biopyrrins levels and Diabetic retinopathy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diabetic retinopathy, total serum Heme oxygenase-1, bilirubin, and Urinary Biopyrrins levels
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with diabetes
Key exclusion criteria	Those who decline this study
Target sample size	300

Research contact person
Name of lead principal investigator	Toyoshi Inoguchi
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Medicine and Bioregulatory
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL	092-642-5284
Email	kanakudo@med.kyushu-u.ac.jp

Public contact
Name of contact person	Toyoshi Inoguchi
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Medicine and Bioregulatory
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL	092-642-5284
Homepage URL
Email	kanakudo@med.kyushu-u.ac.jp

Sponsor
Institute	Department of Medicine and Bioregulatory, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	Department of Medicine and Bioregulatory, Graduate School of Medical Sciences, Kyushu University
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	2016 Year 12 Month 10 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 12 Month 10 Day
Anticipated trial start date	2016 Year 12 Month 10 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	non

Management information
Registered date	2016 Year 11 Month 30 Day
Last modified on	2016 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028794