UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000559 |
|---|---|
| Receipt number | 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 10:46:30 |
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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
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
nsato@kyotolan.hosp.go.jp
Sponsor or person
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
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000677
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
