UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006244
Receipt number R000007391
Scientific Title Multiclinical Study for Diabetic Macrovascular complications(MSDM)
Date of disclosure of the study information 2011/08/29
Last modified on 2011/08/31 15:47:44

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Basic information

Public title

Multiclinical Study for Diabetic Macrovascular complications(MSDM)

Acronym

MSDM

Scientific Title

Multiclinical Study for Diabetic Macrovascular complications(MSDM)

Scientific Title:Acronym

MSDM

Region

Japan


Condition

Condition

To clarify the clinical features of diabetic macroangiopathy in our country and to set up the control critelia for the multiple risk factors.

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clearify the clinical features of diabetic macroangiopathy(MA) and find out control critelia for the onset and progression of MA.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase IV


Assessment

Primary outcomes

Incidence and clinical features of MA and the relationship between MA and various riskfactors have been followed clinically in multiple facilities.

Key secondary outcomes

Relationship between MA and microvascular complications has been evaluated.


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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

type 2 diabetes with or without MA,who chan be followed periodically in out patient clinic.

Key exclusion criteria

those who can not visit clinic periodically or age above 80.
Brain hemorrhage was removed from CVD.

Target sample size

900


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Harano Yutaka

Organization

Niseikai Centar for Lifestyle Deseases

Division name

Niseikai Centar for Lifestyle Deseases

Zip code


Address

7-14-17,Niina,Mino-City,OSAKA

TEL

072-700-1135

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

MSDM

Division name

Niseikai Centar

Zip code


Address


TEL


Homepage URL


Email

yharano_life@hcn.zaq.ne.jp


Sponsor or person

Institute

MSDM

Institute

Department

Personal name



Funding Source

Organization

Adult Vascular Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

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

2011 Year 08 Month 29 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


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

1990 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

1990 Year 04 Month 01 Day

Last follow-up date

2001 Year 12 Month 01 Day

Date of closure to data entry

2006 Year 12 Month 01 Day

Date trial data considered complete


Date analysis concluded

2006 Year 12 Month 01 Day


Other

Other related information

Registar tupe 2 diabetes with or without MA and follow the onset or progression of MA. Data of risk factors for MA were used around the date of onset or when diagnosis was made.


Management information

Registered date

2011 Year 08 Month 29 Day

Last modified on

2011 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007391


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name