UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of contribution of xanthine oxidoreductase on the onset and progression of vascular complications in patients with type 2 diabetes.
Acronym	Analysis of contribution of XOR on the onset and progression of vascular complications in patients with type 2 diabetes.
Scientific Title	Analysis of contribution of xanthine oxidoreductase on the onset and progression of vascular complications in patients with type 2 diabetes.
Scientific Title:Acronym	Analysis of contribution of XOR on the onset and progression of vascular complications in patients with type 2 diabetes.
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship of plasma xanthine oxidoreductase activities with purine structures, vascular complications or their backgrounds in patients with type 2 diabetes.
Basic objectives2	Others
Basic objectives -Others	Activities of the enzyme
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Plasma xanthine oxidoreductase activities
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with type 2 diabetes (T2DM) 2)18 years or older 3)Male or female 4)Patients without liver dysfunction 5)All subjects must be provided written informed consent prior to entry.
Key exclusion criteria	1)Non-T2DM patients 2)Pregnant, breastfeeding, or patients with no contraception 3)Patients currently taking XOR inhibitors 4)Patients who are inappropriate to enter the trial with any safety reasons, judged by the primary doctors.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Midori Middle name Last name Fujishiro
Organization	Nihon University Hospital
Division name	Department of Internal Medicine
Zip code	101-8309
Address	1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL	03-3293-1711
Email	fujishiro.midori@nihon-u.ac.jp

Public contact
Name of contact person	1st name Midori Middle name Last name Fujishiro
Organization	Nihon University Hospital
Division name	Department of Internal Medicine
Zip code	101-8309
Address	1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL	03-3293-1711
Homepage URL
Email	fujishiro.midori@nihon-u.ac.jp

Sponsor
Institute	Nihon University Hospital
Institute
Department

Funding Source
Organization	Self funding
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	Nihon University Hospital
Address	1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
Tel	03-3293-1711
Email	nuhosp.rinri@nihon-u.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 09 Month 23 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	Completed
Date of protocol fixation	2017 Year 07 Month 20 Day
Date of IRB	2017 Year 07 Month 20 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2021 Year 08 Month 26 Day
Date of closure to data entry	2021 Year 08 Month 26 Day
Date trial data considered complete	2021 Year 08 Month 26 Day
Date analysis concluded	2021 Year 08 Month 26 Day

Other
Other related information	Another 2 mL of blood should be taken in addition to the usual blood test

Management information
Registered date	2017 Year 09 Month 23 Day
Last modified on	2021 Year 08 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033440