UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003589 |
|---|---|
| Receipt number | R000004354 |
| Scientific Title | Development of diabetes prevention program in offspring of patients with type 2 diabetes: Randomized Controlled Trial of education about genetic susceptibility and preventive strategy. |
| Date of disclosure of the study information | 2010/05/10 |
| Last modified on | 2013/08/18 22:50:14 |
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Basic information
Public title
Development of diabetes prevention program in offspring of patients with type 2 diabetes: Randomized Controlled Trial of education about genetic susceptibility and preventive strategy.
Acronym
Randomized control trial of genetic/preventive education in adult offspring of patients with type 2 diabetes
Scientific Title
Development of diabetes prevention program in offspring of patients with type 2 diabetes: Randomized Controlled Trial of education about genetic susceptibility and preventive strategy.
Scientific Title:Acronym
Randomized control trial of genetic/preventive education in adult offspring of patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type2 Diabetes
Classification by specialty
| Endocrinology and Metabolism | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effect of education about genetic susceptibility and prevention strategy on preventive behavior in adult offspring of patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Compliance to lifestyle intervention
Key secondary outcomes
Dietary/Physical activity habits, BMI, HbA1C, Fasting blood glucose
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Educational session about genetic susceptibility and preventivce strategy by genetic counselor in face-to-face manner and indirect, tailored lifestyle intervention
Interventions/Control_2
indirect, tailored lifestyle intervention
Interventions/Control_3
Control
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult offspring of patient with type 2 diabetes who visits medical check up
Key exclusion criteria
Visitants who has already diagnosed type 2 diabetes.
Subjects who meet Special Healthcare Guidance Program criteria after check-up will be excluded from indirect lifestyle intervention.
Target sample size
225
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu, NISHIGAKI |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Adult Nursing, School of Health Schiences and Nursing
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5841-3609
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakazu, NISHIGAKI |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Adult Nursing, School of Health Schiences and Nursing
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5841-3609
Homepage URL
Sponsor or person
Institute
Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Social Insurance Chuo General Hospital
Name of secondary funder(s)
The Japan Foundation
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
社会保険総合中央病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 10 | 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
Completed
Date of protocol fixation
| 2010 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 10 | Day |
Last modified on
| 2013 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004354
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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