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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000169
Receipt No. 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

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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
Email

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
Email makoto@jichi.ac.jp

Sponsor
Institute ICPD study Research Group
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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