UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020937 |
|---|---|
| Receipt number | R000024122 |
| Scientific Title | Analysis of the association between plasma xanthine oxidoreductase activity and atherosclerosis in the patients with metabolic diseases. |
| Date of disclosure of the study information | 2016/02/08 |
| Last modified on | 2019/08/26 20:42:52 |
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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
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
shou.tanaka@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Sakura Medical Center
Center of Diabetes,Endocrinology and Metabolism
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024122
