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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003136
Receipt No. R000003799
Scientific Title Lifestyle intervention using existing human resources on the development of type 2 diabetes
Date of disclosure of the study information 2010/02/03
Last modified on 2010/02/03

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Basic information
Public title Lifestyle intervention using existing human resources on the development of type 2 diabetes
Acronym Japan Diabetes Prevention Program
Scientific Title Lifestyle intervention using existing human resources on the development of type 2 diabetes
Scientific Title:Acronym Japan Diabetes Prevention Program
Region
Japan

Condition
Condition impaired glucose tolerance
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To determine the effct of a lifestyle intervention carried out in primary health care settings, on the development of diabetes in Japanese with impaired glucose tolerance
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Cumulative incidence of diabetes mellitus
Key secondary outcomes Changes of body weight, BMI, waist cicumference, blood glucose, insulin, HbA1c, blood pressure, lipids, liver function, and health behavior

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 During the initial six months, four group session were conducted and an individual session is conducted biannually by public health nurses or dieticians.
Interventions/Control_2 The control group received only general verbal and written information on a healthy lifestyle and diabetes in one group session by public health nurses or dietician.
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
60 years-old >
Gender Male and Female
Key inclusion criteria Subjects with impired glucose tolerance (IGT), aged 30-60 years, were recruited through helath checkups conducted at 32 collaborative center. The recruitment started in March 1999 and was completed in December 2002. A two-step strategy was adopted for indentifying subjects with IGT. The criteria were: 1) fasting plasma glucose >=5.6mmol/l but <7.0 mmol/l, 2) casual plasma glucose (CPG) >=7.8mmol/l but <11.1mmol/l when blood was drawn within 2 hours after a meal, or CPG >=6.1mmol/l but 7.8mmol/l when blood was drawn 2 hours or more after meal, or 3) a diagnosis of IGT based on a previous 75 g oral glucose test. Then, IGT were diagnosed based on the World Health Organization's criteria.
Key exclusion criteria 1) a preveous diagnosis of diabetes mellitus other than gestational diabetes
2) a history of gastrectomy
3) physical conditions such as ischemic heart disease, heart failure, exercise-induced asthma and orhopedic problems where exercise was not allowed by a doctor,
4) deinitive liver and kidney diseases 5) autoimmune diseases
6) a hibit of heavy alcohol drinking
Target sample size 314

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideshi Kuzuya
Organization National Hospital Organization Kyoto Medical Center
Division name Clinica Research Institute
Zip code
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, 612-8555 JAPAN
TEL 075-641-9161
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Sakane
Organization Natiional Hospital Organization Kyoto Medical Center
Division name Clinical Research Institute
Zip code
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, 612-8555 JAPAN
TEL 075-641-9161
Homepage URL
Email nsakane@kyotolan.hosp.go.jp

Sponsor
Institute Natiional Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 Otaru City Health Center, Mizusawa Health Center, Funagata Town Health Center, Kasagake Town Health Center, Toyota Kenpo, Rakuwakai Healthcare System, Toyooka City Health Center, Kasai City Health Center, Mitoyo Municipal Eikou Hospital, Kumamoto General Health Center, Kyusyu Health Center, Nakagawa Health Center, Sue Town Health Center, Shime Town Health Center, Kasuya Town Health Center, Sasaguri Town Health Center, Hisayama Health C & C Center, KDD Shinjyuku Health Center, Aichi Health Promotion Center, Ashibetu Health Center, Kanie Town Health Center, Ohara Hospital, Kakogawa City Health Center, Chiba City Health Promotion Center, Inuyamacyuo Hospital, AIR WATER KENPO, Haruhi Town Health Center, OKA KOUKI Health Management Center, Shikatsu Town Health Center, Nisibiwa Town Health Center, Hikami Town Health Center, and Tomari Town Health Center

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially 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
1998 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
1999 Year 03 Month 01 Day
Last follow-up date
2006 Year 01 Month 01 Day
Date of closure to data entry
2006 Year 02 Month 01 Day
Date trial data considered complete
2006 Year 02 Month 01 Day
Date analysis concluded
2010 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 03 Day
Last modified on
2010 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003799

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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