UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021598 |
|---|---|
| Receipt number | 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 12:37:28 |
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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
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
ykusu@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of medicine, innovative diabetes treatment
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024873
