UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007581 |
|---|---|
| Receipt number | R000008506 |
| Scientific Title | The relationship between blood glucose fluctuations and vascular endothelial dysfunction from CGM in type 2 diabetes mellitus |
| Date of disclosure of the study information | 2012/03/28 |
| Last modified on | 2013/03/27 10:47:47 |
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Basic information
Public title
The relationship between blood glucose fluctuations and vascular endothelial dysfunction from CGM in type 2 diabetes mellitus
Acronym
The relationship between blood glucose fluctuations and vascular endothelial dysfunction from CGM in type 2 diabetes mellitus
Scientific Title
The relationship between blood glucose fluctuations and vascular endothelial dysfunction from CGM in type 2 diabetes mellitus
Scientific Title:Acronym
The relationship between blood glucose fluctuations and vascular endothelial dysfunction from CGM in type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we investigated the relationship between blood glucose fluctuations and vascular endothelial function in actual medical practice
Basic objectives2
Others
Basic objectives -Others
cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the relationship between vascular endothelial function (RHI) and blood glucose fluctuations
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
type 2 diabetes mellitus patients who were admitted to the Wakamatsu Hospital of the University of Occupational and Environmental Health
Key exclusion criteria
arrhythmic patients
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiya Tanaka |
Organization
School of Medicine, University of Occupational and Environmental Health
Division name
First Department of Internal Medicine
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku Kitakyushu 807-8555, Japan
TEL
093-603-1611
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
School of Medicine, University of Occupational and Environmental Health
Division name
First Department of Internal Medicine
Zip code
Address
TEL
090-603-1611
Homepage URL
kobekt79@gmail.com
Sponsor or person
Institute
First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan
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
| 2012 | Year | 03 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 08 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 31 | Day |
Other
Other related information
a continuous glucose monitoring system (CGMS® System GoldTM, Medtronic Inc) is installed from the 2nd or 3rd hospital day to measure blood glucose fluctuations. A peripheral arterial tonometry (PAT) device (EndoPAT2000, Itamar Medical Ltd, Caesarea, Israel) is used to measure the reactive hyperemia index (RHI) on the 3rd or 4th hospital day in order to evaluate the vascular endothelial function.
Management information
Registered date
| 2012 | Year | 03 | Month | 27 | Day |
Last modified on
| 2013 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008506
