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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001663
Receipt No. R000002009
Scientific Title Analysis of gene expression profiles of peripheral blood cells in obese subjects
Date of disclosure of the study information 2010/01/31
Last modified on 2017/07/23

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Basic information
Public title Analysis of gene expression profiles of peripheral blood cells in obese subjects
Acronym Obesity and gene expression in peripheral blood cells
Scientific Title Analysis of gene expression profiles of peripheral blood cells in obese subjects
Scientific Title:Acronym Obesity and gene expression in peripheral blood cells
Region
Japan

Condition
Condition Obesity
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of present study is to clarify the association of gene expression profiles in peripheral blood cells between malignant obesity and benign obesity.
Basic objectives2 Others
Basic objectives -Others We evaluate the differences of mRNA expression levels of peripheral blood cells between malignant obesity and benign obesity.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes We evaluate the differences of mRNA expression levels of peripheral blood cells between malignant obesity and benign obesity.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria Among inpatients and outpatients admitted to Osaka University Hospital, obese subjects satisfied with the criteria of Japan Society for the Study of Obesity are enrolled in present study.
Key exclusion criteria Subjects who cannot understand the informed consent.
Subjects whom chief physician judge on unsuitable for this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Iichiro Shimomura
Organization Graduate School of Medicine, Osaka University
Division name Department of Metabolic Medicine
Zip code
Address 2-2-B5, Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-3732
Email

Public contact
Name of contact person
1st name
Middle name
Last name Norikazu Maeda
Organization Graduate School of Medicine, Osaka University
Division name Department of Metabolic Medicine
Zip code
Address 2-2-B5, Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-3732
Homepage URL
Email nmaeda@imed2.med.osaka-u.ac.jp

Sponsor
Institute Department of Metabolic Medicine, Graduate School of Medicine, Osaka University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2010 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2009 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
2014 Year 03 Month 01 Day
Date trial data considered complete
2014 Year 03 Month 01 Day
Date analysis concluded
2017 Year 07 Month 01 Day

Other
Other related information We evaluate the differences of mRNA expression levels of peripheral blood cells between malignant obesity and benign obesity. This study is a prospective study and blood samples are randomly collected.

Management information
Registered date
2009 Year 01 Month 27 Day
Last modified on
2017 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002009

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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