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
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
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
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
