UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004591 |
|---|---|
| Receipt number | R000005483 |
| Scientific Title | Development of a intensified diabetes intervention program at work places |
| Date of disclosure of the study information | 2011/12/31 |
| Last modified on | 2016/11/25 12:22:23 |
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Basic information
Public title
Development of a intensified diabetes intervention program at work places
Acronym
Development of a intensified diabetes intervention program at work places
Scientific Title
Development of a intensified diabetes intervention program at work places
Scientific Title:Acronym
Development of a intensified diabetes intervention program at work places
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We intend to develop an intensified intervention program for diabetic employees to modify their life style, which is easily executable and efficient at work places that do not have thier own medical facilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1c
calorie intake
exercise level
Key secondary outcomes
anti-diabetic drug usage
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
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1. Lecture regarding life style modifycation (at the time of enrollment)
2. Monthly 30 min interview
3. HbA1c measurement and physical examination at each interview (Data feedbacked to the subjects)
Interventions/Control_2
Lecture regarding life style modifycation (at the time of enrollment)
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diabetic patients in entities with employees participating in a study, entitled 'A cohort study to reveal factors that contribute to the onset of diabetes/metabolic syndrome through a development of insulin resistance'
Diabetic patients are defined as individuals with FBS <= 126 mg/dl or HbA1c <= 6.5%, or individuals treated with anti-diabetic medication due to a diagnosis of diabetes.
Out of diabetic patients described above, individuals who 1. give written consents for participation, 2. are male or female, 3. aged betweem 20 and 65 are eligible.
Key exclusion criteria
Individuals without written consents
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Funaki |
Organization
Tokushima University Hospital
Division name
Clinical Research Center for Diabetes
Zip code
Address
2-50-1 Kuramoto-cho Tokushima Japan
TEL
088-633-9679
m-funaki@clin.med.tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Funaki |
Organization
Tokushima University Hospital
Division name
Clinical Research Center for Diabetes
Zip code
Address
2-50-1 Kuramoto-cho Tokushima Japan
TEL
088-633-9679
Homepage URL
m-funaki@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Clinical Research Center for Diabetes
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Medical Treatment Recovery Care Nursing
Institute of Health Biosciences
University of Tokushima Graduate School
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
徳島大学病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 19 | Day |
Last modified on
| 2016 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005483
