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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006015
Receipt No. R000007119
Scientific Title Expression analysis of the innate immunity-associated molecules in obesity and adipose tissue inflammation
Date of disclosure of the study information 2011/07/20
Last modified on 2016/07/22

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Basic information
Public title Expression analysis of the innate immunity-associated molecules in obesity and adipose tissue inflammation
Acronym Expression analysis of the innate immunity-associated molecules in adipose tissue inflammation
Scientific Title Expression analysis of the innate immunity-associated molecules in obesity and adipose tissue inflammation
Scientific Title:Acronym Expression analysis of the innate immunity-associated molecules in adipose tissue inflammation
Region
Japan

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

Objectives
Narrative objectives1 In a previous study, we found that a high-fat diet (HFD) increased the levels of RP105 and MD-1 mRNA in epididymal white adipose tissue (eWAT). We also found that RP105 and MD-1 were expressed by adipose tissue macrophages (ATMs) and HFD increased RP105 expression on the M1 subset. Furthermore, RP105- or MD-1-deficient mice had less HFD-induced adipose tissue inflammation, hepatic steatosis and insulin resistance compared to wild-type mice. Above findings clearly indicate that RP105/MD-1 plays a major role in regulating adipose tissue inflammation and metabolic disorders.
In this study, we will determine whether RP105/MD-1 and other innate immunity-associated molecules are involved in obesity and adipose tissue inflammation in human. To approach this, we will investigate whether their expression levels in adipose tissue correlate with body mass index (BMI) and the levels of blood glucose.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We will investigate whether the expression levels of innate immunity-associated molecules in human adipose tissue correlate with body mass index (BMI).
Key secondary outcomes

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 Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Adipose tissue will be collected from patients who will receive urological or cardiac blood vessel surgery.
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 Patients who will receive urological or cardiac blood vessel surgery at Tokushima University Hospital and agree with this study
Key exclusion criteria Patients who disagree with this study
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinori Nagai
Organization University of Toyama
Division name Graduate School of Medicine and Pharmaceutical Science for Research
Zip code
Address 2630 Sugitani, Toyama-shi, Toyama 930-0194, Japan
TEL 076-434-7673
Email ynagai@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Nagai
Organization University of Toyama
Division name Graduate School of Medicine and Pharmaceutical Science for Research
Zip code
Address 2630 Sugitani, Toyama-shi, Toyama 930-0194, Japan
TEL 076-434-7673
Homepage URL
Email ynagai@med.u-toyama.ac.jp

Sponsor
Institute Department of Immunobiology and Pharmacological Genetics, Graduate School of Medicine and Pharmaceutical Science for Research, University of Toyama
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor The University of Tokushima
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
2011 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/22396206
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
2011 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
2016 Year 03 Month 30 Day
Date trial data considered complete
Date analysis concluded
2016 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2011 Year 07 Month 20 Day
Last modified on
2016 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007119

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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