UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007358 |
|---|---|
| Receipt number | R000006517 |
| Scientific Title | Japan Diabetes & Obesity Study (J-DOS) 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 | 2012/02/22 |
| Last modified on | 2013/03/21 20:35:24 |
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Basic information
Public title
Japan Diabetes & Obesity Study (J-DOS) supported by Clinical Study of Network for Endocrine and metabolic Diseases, Policy-Based Medical Service of National Hospital Organization.
Acronym
Japan Diabetes & Obesity Study (J-DOS)
Scientific Title
Japan Diabetes & Obesity Study (J-DOS) supported by Clinical Study of Network for Endocrine and metabolic Diseases, Policy-Based Medical Service of National Hospital Organization.
Scientific Title:Acronym
Japan Diabetes & Obesity Study (J-DOS)
Region
| Japan |
Condition
Condition
Diabetes, Obesity
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Identification of early predictive indicators in lipid profile and inflammatory molecules for preventing cardiovasucular disease.
Basic objectives2
Others
Basic objectives -Others
Establishment of effective treatment programs for the prevention of cardio-renal interaction.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Cardio Ankle Vascular Index: CAVI
2.eGFR and CKD stage
Key secondary outcomes
The incidence of cardiovascular disease and chronic kidney disease, and total mortality
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
1)Diet therapy:
i)30kcal/kg of ideal body weight per day for diabetic patients.
ii)25kcal/kg of ideal body weight per day for obese patients.
2)Exercise therapy:
10,000 step walking per day, or exercise of 15-30 minutes at 2 times per day.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) type 2 diabetes patients.
2) obese patients, Body Mass Index (BMI) is more than 25.
Key exclusion criteria
1) Severe Liver Dysfunction and Liver cirrhosis.
2) Severe Renal Dysfunction.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriko Satoh |
Organization
Clinical Research Institute, National Hospital Organization, Kyoto Medical Center
Division name
Division of Diabetes
Zip code
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto-city
TEL
0756419161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Satoh |
Organization
Clinical Research Institute, National Hospital Organization, Kyoto Medical Center
Division name
Division of Diabetes
Zip code
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto-city
TEL
0756419161
Homepage URL
nsato@kyotolan.hosp.go.jp
Sponsor or person
Institute
Japan Diabetes & Obesity Study (J-DOS) Network Group.
Institute
Department
Personal name
Funding Source
Organization
Multi-centered Clinical Research, the Policy-Based Medical Service Network, 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
国立病院機構 京都医療センター、小倉医療センター、名古屋医療センター、三重病院、長崎川棚医療センター、九州医療センター、徳島病院、金沢医療センター、熊本医療センター、函館病院、長野病院、三重中央医療センター、埼玉病院、宇治徳洲会病院、広島西医療センター、大石内科クリニック
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 22 | 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
| 2010 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 22 | Day |
Last modified on
| 2013 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006517
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
