UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029970 |
|---|---|
| Receipt number | R000034221 |
| Scientific Title | The association of circulating xanthine oxidase activity and purines with peripheral neuropathy or cognitive functions in type 2 diabetes. |
| Date of disclosure of the study information | 2017/11/15 |
| Last modified on | 2022/11/22 19:06:53 |
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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
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
oku_tomo@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034221
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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