UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of the association between plasma xanthine oxidoreductase activity and atherosclerosis in the patients with metabolic diseases.
Acronym	Analysis of the association between plasma xanthine oxidoreductase activity and atherosclerosis in the patients with metabolic diseases.
Scientific Title	Analysis of the association between plasma xanthine oxidoreductase activity and atherosclerosis in the patients with metabolic diseases.
Scientific Title:Acronym	Analysis of the association between plasma xanthine oxidoreductase activity and atherosclerosis in the patients with metabolic diseases.
Region	Japan

Condition
Condition	Life-style related diseases.(Type 2 diabetes,dyslipidemia,hypertension,obesity)
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study attempts to reveal the association between plasmaXOR activity,uric acid, vascular function and states of life-style related diseases,including type2 diabetes,dyslipidemia,hypertension and obesity.
Basic objectives2	Others
Basic objectives -Others	This study attempts to reveal the association between plasmaXOR activity,uric acid, vascular function and states of life-style related diseases,including type2 diabetes,dyslipidemia,hypertension and obesity.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Plasma xanthine oxidoreductase activity
Key secondary outcomes	1)body weight,blood pressure 2)uric acid,blood glucose,HbA1c,liver function,lipid parameter(TC,TG,HDL-C,LDL-C) 3)serum creatinine,urinary albumin 4)CAVI:Cardio-ankle vascular index

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	1.20 years and over 2.Patients without any hypouricemic agent and who have any of following life-style related diseases. (3-6) 3.Type 2 diabetes mellitus HbA1c6.5% and over(untreated) HbA1c4.8% and over(treated) 4.dyslipidemia 5.hypertension 6.obesity 7.Patients who themselves can voluntarily provide consent to participate in this study
Key exclusion criteria	1.Ptients who are judged as inappropriate for inclusion by physicians. 2.Patients who can not be measured CAVI a.severe arteriosclerosis obliterans b.arterial fibrillation
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Ichiro Middle name Last name Tatsuno
Organization	Toho University Sakura Medical Center
Division name	Center of Diabetes,Endocrinology and Metabolism
Zip code	285-8741
Address	564-1,Shimoshizu,Sakura-City,Chiba
TEL	043-462-8811
Email	ichiro.tatsuno@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Shou Middle name Last name Tanaka
Organization	Toho University Sakura Medical Center
Division name	Center of Diabetes,Endocrinology and Metabolism
Zip code	285-8741
Address	564-1,Shimoshizu,Sakura-City,Chiba
TEL	043-462-8811
Homepage URL
Email	shou.tanaka@med.toho-u.ac.jp

Sponsor
Institute	Toho University Sakura Medical Center Center of Diabetes,Endocrinology and Metabolism
Institute
Department

Funding Source
Organization	SANWA KAGAKU KENKYUSHO CO.,LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	SANWA KAGAKU KENKYUSHO CO.,LTD
Name of secondary funder(s)	not applicable

IRB Contact (For public release)
Organization	Toho University Sakura Medical Center
Address	564-1,Shimoshizu,Sakura-City,Chiba
Tel	043-462-8811
Email	soumu@sakura.med.toho-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	東邦大学医療センター佐倉病院（千葉県）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 08 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	Open public recruiting
Date of protocol fixation	2016 Year 01 Month 15 Day
Date of IRB	2017 Year 03 Month 03 Day
Anticipated trial start date	2016 Year 01 Month 15 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information	Observational study:cross sectional study Metabolic syndrome patients

Management information
Registered date	2016 Year 02 Month 08 Day
Last modified on	2019 Year 08 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024122