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

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 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


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

Value
https://center6.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