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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001959
Receipt No. R000002389
Scientific Title Randomized multi-institutional study for effectiveness of intervention on life style in obese patients with fasting hyperglycemia or abnormal glucose tolerance test.
Date of disclosure of the study information 2009/05/12
Last modified on 2009/05/12

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Basic information
Public title Randomized multi-institutional study for effectiveness of intervention on life style in obese patients with fasting hyperglycemia or abnormal glucose tolerance test.
Acronym ZPLS
Scientific Title Randomized multi-institutional study for effectiveness of intervention on life style in obese patients with fasting hyperglycemia or abnormal glucose tolerance test.
Scientific Title:Acronym ZPLS
Region
Japan

Condition
Condition Diabetes mellitus
(Pre-diabetes )
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to clarify that behavioural improvement in life style including food intake and physical exercise in patients with pre-diabetes can prevent development of diabetes mellitus and whether the frequency of intervention by medical staffs influences prevention of the disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes incidence of diabetes mellitus
Key secondary outcomes

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 NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Frequent intervention: During three years, totally ten times of interview by medical doctors, guidance for life style by nurses and laboratory examinations such as fasting blood sugar, immuno-reactive insulin and fibronectin.
Interventions/Control_2 Infrequent intervention: During three years, once-a-year performance of an interview by medical doctors, guidance for life style by nurses and laboratory examinations such as fasting blood sugar, immuno-reactive insulin and fibronectin per year.
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 Men and women over 30 and under 60 years old who fulfill the following two criteria:1) the body mass index is more than 24kg/m2 and 2) the level of fasting blood sugar is more than 100mg/dl and less than 126mg/dl
Key exclusion criteria 1) An individual who has a history of diabetes mellitus
2) An individual who is performing treatment for improvement of life style as food intake and physical exercise under the supervision of a medical doctor
3) An individual who has the following diseases or has a history of the following diseases
(1) ischemic heart disease
(2) cerebro-vascular disease
(3) chronic hepatitis
(4) liver cirrhosis
(5) chronic pancreatitis
(6) chronic nephritis
(7) diseases of the pituitary gland
(8) diseases of the thyroid gland
(9) diseases of the adrenal gland
(10) psychological impairment
(11) status of post-gastrectomy
(12) malignancy in an advanced stage
4) An individual who takes following drugs
(1) steroid hormone
(2) thyroid hormone
(3) beta-blocker
(4) diuretics
5) An individual who is judged as inappropriate for this study by a medical doctor
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshikazu Saito
Organization Chuou General Hospital of Social Insurance
Division name Department of Internal Medicine
Zip code
Address 3-22-1 Hyakunin-cho,Shinjuku-ku Tokyo, 169-0073, Japan
TEL 03-3364-6216
Email

Public contact
Name of contact person
1st name
Middle name
Last name Junko Nishida
Organization Chuou General Hospital of Social Insurance
Division name Department of Internal Medicine
Zip code
Address 3-22-1 Hyakunin-cho,Shinjuku-ku Tokyo, 169-0073, Japan
TEL 03-3364-6216
Homepage URL
Email

Sponsor
Institute All Japan Federation of Social Insurance Associations
Institute
Department

Funding Source
Organization All Japan Federation of Social Insurance Associations
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 12 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 No longer recruiting
Date of protocol fixation
2004 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2004 Year 05 Month 01 Day
Last follow-up date
2009 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 05 Month 12 Day
Last modified on
2009 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002389

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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