UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022081 |
|---|---|
| Receipt number | R000023731 |
| Scientific Title | The effects of glucosamine modification on endothelial cells of diabetic angiopathy |
| Date of disclosure of the study information | 2016/04/27 |
| Last modified on | 2018/04/28 11:48:03 |
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Basic information
Public title
The effects of glucosamine modification on endothelial cells of diabetic angiopathy
Acronym
The effects of glucosamine modification on endothelial cells of diabetic angiopathy
Scientific Title
The effects of glucosamine modification on endothelial cells of diabetic angiopathy
Scientific Title:Acronym
The effects of glucosamine modification on endothelial cells of diabetic angiopathy
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To ensure that O-GlcNAc is more abundant in the endothelium of diabetic patients
Basic objectives2
Others
Basic objectives -Others
To investigate whether drugs reducing O-GlcNAc in endothelial cells improve eNOS activity.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
p-eNOS(Ser1177)
Key secondary outcomes
DAF-2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who are planned to take coronary catheter examination
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Masaki |
Organization
National Defense Medical College
Division name
Intensive Care Medicine
Zip code
Address
3-2, Namiki, Tokorozawa, Saitama, Japan
TEL
1-81-429-95-1211
masakinobuyuki@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Masaki |
Organization
National Defense Medical College
Division name
Intensive Care Medicine
Zip code
Address
3-2, Namiki, Tokorozawa, Saitama, Japan
TEL
1-81-429-95-1211
Homepage URL
masakinobuyuki@hotmail.com
Sponsor or person
Institute
Ministry of Defense
Institute
Department
Personal name
Funding Source
Organization
Ministry of Defense
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 04 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The results were presented at annual meeting of Japanese Circulation Society (Osaka 2018,3), and Vascular Failure (Kyoto 2018.4)
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 | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Enrolling patients
Management information
Registered date
| 2016 | Year | 04 | Month | 26 | Day |
Last modified on
| 2018 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023731
