UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006239 |
|---|---|
| Receipt number | R000007382 |
| Scientific Title | Multiple Risk Factor Control Trial |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2020/03/18 12:27:18 |
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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
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
yharano_life@hcn.zaq.ne.jp
Sponsor or person
Institute
Study group for macrovascular complications(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
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
Value
https://center6.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 |
