UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007581
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email kobekt79@gmail.com

Sponsor
Institute First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan
Institute
Department

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
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
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&#174; 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008506

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.