UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003136 |
|---|---|
| Receipt number | 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 16:07:59 |
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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
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
nsakane@kyotolan.hosp.go.jp
Sponsor or person
Institute
Natiional Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003799
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