UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006015 |
|---|---|
| Receipt number | 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 11:23:42 |
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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
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
ynagai@med.u-toyama.ac.jp
Sponsor or person
Institute
Department of Immunobiology and Pharmacological Genetics, Graduate School of Medicine and Pharmaceutical Science for Research, University of Toyama
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007119
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
