UMIN-CTR Clinical Trial

Basic information
Public title	The association of circulating xanthine oxidase activity and purines with peripheral neuropathy or cognitive functions in type 2 diabetes.
Acronym	The xanthine oxidase activity in type 2 diabetes.
Scientific Title	The association of circulating xanthine oxidase activity and purines with peripheral neuropathy or cognitive functions in type 2 diabetes.
Scientific Title:Acronym	The xanthine oxidase activity in type 2 diabetes.
Region	Japan

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

Objectives
Narrative objectives1	To clarify the correlation between circulating xanthine oxidase activity and peripheral neuropathy or cognitive impairment in type 2 diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The association of circulationg xanthine oxidase activity and sensetion level with monofilaments or cognitive functions.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients diagnosed with type 2 diabetes 2)Aged over 20. 3)Patients responsible to cognitive functional tests. 4)Having provided voluntary written consent for participation in this study.
Key exclusion criteria	1)Patients with severe complications (liver disease, mental disorder, or cancer). 2)Patients with severe ketosis or diabetic coma. 3)Patients with severe infections, perioperative status, or severe trauma. 4)Patients whose baseline eGFR were <30 ml/min/1.73m^2. 5)Patients treated with uric acid synthesis inhibitor, drugs for dimentia or drugs for neuropathy. 6)Patients who are judged by an investigator to be inappropriate for this study for any other reason.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuo Terauchi
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Endocrinology and Metabolism
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2800
Email	terauchi@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tomoko Okuyama
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Endocrinology and Metabolism
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2800
Homepage URL
Email	oku_tomo@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	None
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 11 Month 15 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 10 Month 13 Day
Date of IRB	2017 Year 10 Month 23 Day
Anticipated trial start date	2017 Year 11 Month 15 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	Cross-sectional study Recruitment of Subject: Inpatients with type 2 diabetes in Yokohama City University hospital who fulfilled the inclusion/exclusion criteria from November 15th,2017 to March 31, 2020. To evaluate the physiological significance of circulating xanthine oxidase activityfor peripheral neuropathy or cognitie functions in patients with type 2 diabetes

Management information
Registered date	2017 Year 11 Month 14 Day
Last modified on	2022 Year 11 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034221