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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006239
Receipt No. R000007382
Scientific Title Multiple Risk Factor Control Trial
Date of disclosure of the study information 2011/09/01
Last modified on 2020/03/18

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Basic information
Public title Multiple Risk Factor Control Trial
Acronym MRFACT
Scientific Title Multiple Risk Factor Control Trial
Scientific Title:Acronym MRFACT
Region
Japan

Condition
Condition Type 2 diabetes with duration more than 5 years age for registration;40-70
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The importance and determination of control criteria of multiple risk factors for the appearance and prevention of diabetic macrovascular complications
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes New onset of macrovascular complications(CAD,CVD,PAD)are evalluated accordiog to criteria for the risk factors(BMI,SBP,DBP,FBS,2hBS,HbA1c,LDL-chol,TG,apo-B)
Key secondary outcomes Relationship between the appearance of diabetic microvascular complications(retinopathy,neuropathy,nephropathy)will be clearified

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Medicine Behavior,custom
Interventions/Control_1 Blood glucose(FBS,2HBS)
Interventions/Control_2 BMI
Interventions/Control_3 SBP,DBP
Interventions/Control_4 LDL-chol
Interventions/Control_5 TG
Interventions/Control_6 ApoB
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Type 2 diabetes with duration more than 5 years
Key exclusion criteria syamptomatic macrovascular complications or those who recieved catheter treatment or bipass operations
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kawakami Masatoshi
Organization Omiya Jichi University Medical colledge
Division name Endocrine, Metabolism
Zip code
Address 1-847,amanuma-cho,Omiyaku,Saitama-City
TEL 03-3979-3611
Email nobukawa@omiya.jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Harano Yutaka
Organization Niseikai Center of lifestyle-related diseases
Division name medicine
Zip code
Address 7-14-17,Niina,Mino-city
TEL 072-700-1135
Homepage URL
Email yharano_life@hcn.zaq.ne.jp

Sponsor
Institute Study group for macrovascular complications(MSDM)
Institute
Department

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 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 No longer recruiting
Date of protocol fixation
2003 Year 04 Month 01 Day
Date of IRB
2015 Year 07 Month 28 Day
Anticipated trial start date
2003 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 08 Month 27 Day
Last modified on
2020 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007382

Research Plan
Registered date File name
2017/11/04 平成29年度糖尿病大血管障害検証study報告会_program最終 .docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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