UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001959 |
|---|---|
| Receipt number | 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 11:13:36 |
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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
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
Sponsor or person
Institute
All Japan Federation of Social Insurance Associations
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002389
