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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022081
Receipt No. 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

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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
Email 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
Email masakinobuyuki@hotmail.com

Sponsor
Institute Ministry of Defense
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023731

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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