UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013910 |
|---|---|
| Receipt number | R000016215 |
| Scientific Title | Effectiveness of Pioneering Program of Specific Health Examinations and Specific Guidance incorporating Metabolic Syndrome |
| Date of disclosure of the study information | 2014/05/08 |
| Last modified on | 2014/05/08 13:35:21 |
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Basic information
Public title
Effectiveness of Pioneering Program of Specific Health Examinations and Specific Guidance incorporating Metabolic Syndrome
Acronym
Effectiveness of Mets Programe
Scientific Title
Effectiveness of Pioneering Program of Specific Health Examinations and Specific Guidance incorporating Metabolic Syndrome
Scientific Title:Acronym
Effectiveness of Mets Programe
Region
| Japan |
Condition
Condition
metabolic syndrome(Diabetes, hypertension, dyslipidemia)
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of study is to examine the effectiveness of health education intervention for lifestyle improvement to individual patients based on SNPs that are associated with their metabolic syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body weight, abdominal circumference, fasting blood glucose, blood pressur etc.
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Gene | Behavior,custom |
Interventions/Control_1
health education intervention for lifestyle improvement to individual patients based on SNPs that are associated with their Mets
Interventions/Control_2
Conventional type intervention for lifestyle improvement
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with metabolic syndrome were assigned randomly to an intervention group (IG) and a non-intervention group (non-IG).
Key exclusion criteria
Those who have not agreed with participation of a program
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohisa Imai |
Organization
National Institute of Public Health
Division name
Information Ceter
Zip code
Address
2-3-6 Minami, Wako, Saitma
TEL
048-458-6168
imaihiro@niph.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohisa Imai |
Organization
National Institute of Public Health
Division name
Center for Public Health Informatics
Zip code
Address
2-3-6 Minami, Wako, Saitama
TEL
048-458-6168
Homepage URL
imaihiro@niph.go.jp
Sponsor or person
Institute
National Institute of Public Health
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
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
| 2014 | Year | 05 | Month | 08 | 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
| 2007 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 08 | Day |
Last modified on
| 2014 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016215
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
