UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001663
Receipt number 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 10:21:26

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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