UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000169 |
|---|---|
| Receipt number | R000000242 |
| Scientific Title | Individual-based Counseling Program for Type 2 Diabetes Prevention (ICPD) |
| Date of disclosure of the study information | 2005/10/01 |
| Last modified on | 2007/09/14 11:50:03 |
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Basic information
Public title
Individual-based Counseling Program for Type 2 Diabetes Prevention (ICPD)
Acronym
ICPD study
Scientific Title
Individual-based Counseling Program for Type 2 Diabetes Prevention (ICPD)
Scientific Title:Acronym
ICPD study
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examin the effect of 4 month Individual-based Counseling Program for Type 2 Diabetes on reducing fasting blood sugar and HbA1c
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
fasting blood sugar levels
HbA1c levels
body weight
Key secondary outcomes
dietary habits
physical activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Individual based health education program based on assement of dietary habits and physical activity.
Interventions/Control_2
periodical blood sampling and counseling
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
| 30 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) FPG between 110 mg/dl and 160 mg/dl, 2) CPG within 3 hours after meal between 150 mg/dl and 210 mg/dl, 3) CPG over 3 hours after meal between 130 mg/dl and 210 mg/dl 4) HBA1c between 5.6 % and 6.7 %;
Key exclusion criteria
treatment for diabetes, having history of hormonal diseases, renal function failure, hepatic disease, pancreatic disease, anemia, angina, myocardial infarction, stroke, post-gastrectomy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIrotsugu Ueshima |
Organization
SHiga University of Medical Sciences
Division name
Health Science
Zip code
Address
Tsukinowacho, Sta, Otsu
TEL
077548-2191
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Watanabe |
Organization
Jichi Medical Scool
Division name
Public Health
Zip code
Address
Minamikawachi-Yakushiji3311-1,Tochigi
TEL
0285-58-7338
Homepage URL
makoto@jichi.ac.jp
Sponsor or person
Institute
ICPD study Research Group
Institute
Department
Personal name
Funding Source
Organization
grants from Ministry of Health, Labor and Welfare.
Organization
Division
Category of Funding Organization
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
| 2005 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 1997 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1997 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 1999 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2000 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2001 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2004 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 12 | Day |
Last modified on
| 2007 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000242
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
