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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000559
Receipt No. R000000677
Scientific Title Japan Obesity & Metabolic Syndrome Study (JOMS) supported by Clinical Study of Network for Endocrine and metabolic Diseases, Policy-Based Medical Service of National Hospital Organization.
Date of disclosure of the study information 2006/12/25
Last modified on 2013/02/23

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Basic information
Public title Japan Obesity & Metabolic Syndrome Study (JOMS) supported by Clinical Study of Network for Endocrine and metabolic Diseases, Policy-Based Medical Service of National Hospital Organization.
Acronym Japan Obesity & Metabolic Syndrome Study (JOMS)
Scientific Title Japan Obesity & Metabolic Syndrome Study (JOMS) supported by Clinical Study of Network for Endocrine and metabolic Diseases, Policy-Based Medical Service of National Hospital Organization.
Scientific Title:Acronym Japan Obesity & Metabolic Syndrome Study (JOMS)
Region
Japan

Condition
Condition Obesity
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Investigate the success rates in weight reduction of Japanese obese patients during diet and exercise therapy and clearfy contributing factors to the therapeutic effect.
Basic objectives2 Others
Basic objectives -Others Evaluate the efficacy of weight reduction in preventing the progression of cardiovascular disease in obese patients.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The success rate of weight reduction.
Detection of the influencing factors in the success rate.
Key secondary outcomes The rate and its characteristic of the Metabolic Syndrome in Japanese Obese patients adn its cheracteristic.
The effects ofweight reduction in preventing the progression of arteriosclerosis (Pulse Wave Velocity: PWV & CAVI) and the onset of cardiovascular disease.


Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Diet (25kcal/kg of ideal body weight per day) and Exercise (more than 30 minutes at moderate intensity at least 3 times per week) therapy for a maximum period of 5 years according to the Japanese Society for Obesity's Guidelines for the treatment of Obesity patients.
Interventions/Control_2
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
20 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria Obese patients, Body Mass Index (BMI) is more than 25.
Key exclusion criteria Severe Liver Dysfunction and Liver cirrhosis
Severe Renal Dysfunction
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriko Satoh
Organization Clinical Research Institute for Endocrine Metabolic Diseases, National Hospital Organization, Kyoto Medical Center
Division name Division of Metabolic Research
Zip code
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto-city
TEL 075-641-9161
Email

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Satoh
Organization Clinical Research Institute, National Hospital Organization, Kyoto M
Division name Division of Metabolic Research
Zip code
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto-city
TEL 075-641-9161
Homepage URL
Email nsato@kyotolan.hosp.go.jp

Sponsor
Institute Japan Obesity and Metabolic Syndrome Study (JOMS) Network Group, Endocrine and Metabolic Diseases Division, National Hospital Organization, supported by Ministry of Health, Labour and Welfare of Japan
Institute
Department

Funding Source
Organization Multi-Institutional Clinical Research, Policy-Based Medical Service, National Hospital Organization
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

Other administrative information
Date of disclosure of the study information
2006 Year 12 Month 25 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
2005 Year 12 Month 23 Day
Date of IRB
Anticipated trial start date
2005 Year 12 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 04 Month 01 Day
Date trial data considered complete
2012 Year 03 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 12 Month 25 Day
Last modified on
2013 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000677

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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