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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000972
Receipt No. R000001108
Scientific Title The strategy for the treatment of steroid obesity:dietary therapy based on the obesity-related genetic polymorphisms
Date of disclosure of the study information 2008/02/01
Last modified on 2008/01/07

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Basic information
Public title The strategy for the treatment of steroid obesity:dietary therapy based on the obesity-related genetic polymorphisms
Acronym The treatment of steroid obesity
Scientific Title The strategy for the treatment of steroid obesity:dietary therapy based on the obesity-related genetic polymorphisms
Scientific Title:Acronym The treatment of steroid obesity
Region
Japan

Condition
Condition Children with renal diseases
Classification by specialty
Endocrinology and Metabolism Nephrology Pediatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Evaluation of dietary therapy efficiency based on genetic polymorphisms in children with steroid obesity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Obesity level (evaluation after 1 year)
Key secondary outcomes BMI (evaluation after 1 year)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 dietary therapy
1-year period
One consultation a month
Interventions/Control_2 No-dietary therapy
1-year period
One consultation a month
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
6 years-old <=
Age-upper limit
18 years-old >
Gender Male and Female
Key inclusion criteria Children with renal diseases
Key exclusion criteria Children with other diseases excluding renal diseases
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Nakamura
Organization Teikyo University School of Medicine
Division name Pediatrics
Zip code
Address 2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL 03-3964-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akio Nakamura
Organization Teikyo University School of Medicine
Division name Pediatrics
Zip code
Address 2-11-1, Kaga, Itabashi-ku, Tokyo
TEL 03-3964-1211
Homepage URL
Email akio@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University School of Medicine
Institute
Department

Funding Source
Organization Mitsukoshi Health and Welfare Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Mitsui Seimei Health and Welfare Foundation

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
2008 Year 02 Month 01 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
Date of protocol fixation
2007 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2007 Year 12 Month 01 Day
Last follow-up date
2012 Year 12 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
2008 Year 01 Month 07 Day
Last modified on
2008 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001108

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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