UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Expression analysis of the innate immunity-associated molecules in obesity and adipose tissue inflammation
Title of the study (Brief title)	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

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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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yoshinori Nagai
Organization	University of Toyama
Division name	Graduate School of Medicine and Pharmaceutical Science for Research
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	Yoshinori Nagai
Organization	University of Toyama
Division name	Graduate School of Medicine and Pharmaceutical Science for Research
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/22396206
Results
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