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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021598
Receipt No. R000024873
Scientific Title Investigation of differences in xanthine oxidoreductase activity between healthy and diabetes subjects
Date of disclosure of the study information 2016/03/24
Last modified on 2016/09/23

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Basic information
Public title Investigation of differences in xanthine oxidoreductase activity between healthy and diabetes subjects
Acronym Relationships between blood glucose fluctuations and xanthine oxidoreductase activity
Scientific Title Investigation of differences in xanthine oxidoreductase activity between healthy and diabetes subjects
Scientific Title:Acronym Relationships between blood glucose fluctuations and xanthine oxidoreductase activity
Region
Japan

Condition
Condition type 1 diabetes, type 2 diabetes, healthy
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In the present study, XOR activity in healthy, type 1, and type 2 diabetes subjects is measured in order to verify differences in XOR activity in subjects with different conditions.
Basic objectives2 Others
Basic objectives -Others cross-sectional
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. XOR reactivity
Key secondary outcomes hs-CRP, uric acid, urine albumin, urine protein, cystatin C, creatinin, glucose, CGM, etc

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 The aim of this study is to verify differences in XOR activity in subjects with different conditions.
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
85 years-old >
Gender Male and Female
Key inclusion criteria healthy volunteer, patients with diabetes
Key exclusion criteria The exclusion criteria were as follows: 1) patients who took a a therapeutic agent for hyperuricemia, and 2) patients who were disqualified by the attending physician.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Katsuno
Organization Hyogo college of medicine
Division name Innovative diabetes treatment
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6592
Email ykusu@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiki Kusunoki
Organization Hyogo college of medicine
Division name Innovative diabetes treatment
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6592
Homepage URL
Email ykusu@hyo-med.ac.jp

Sponsor
Institute Hyogo college of medicine, innovative diabetes treatment
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
2016 Year 03 Month 24 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 01 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information XOR activity, glucose fluctuation, diabetic nephropathy, arteriosclerosis, etc.

Management information
Registered date
2016 Year 03 Month 24 Day
Last modified on
2016 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024873

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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