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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016823
Receipt No. R000019514
Scientific Title Clinical significance of adipose tissue-derived hormones and bioactive substances: physiological differences between visceral and subcutaneous adipose tissue
Date of disclosure of the study information 2015/03/17
Last modified on 2015/03/17

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Basic information
Public title Clinical significance of adipose tissue-derived hormones and bioactive substances: physiological differences between visceral and subcutaneous adipose tissue
Acronym Physiological differences between visceral and subcutaneous adipose tissues
Scientific Title Clinical significance of adipose tissue-derived hormones and bioactive substances: physiological differences between visceral and subcutaneous adipose tissue
Scientific Title:Acronym Physiological differences between visceral and subcutaneous adipose tissues
Region
Japan

Condition
Condition obesity
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 In this study, we will assess the expression of a series of hormones and bioactive substances in visceral and subcutaneous adipose tissues from surgical patients. The aim of this study is to reveal the clinical significance of adipose-derived factors in the pathophysiology of human diseases associated with obesity, which will help us to develop new strategies for the prevention and control of metabolic syndrome, inflammatory disorders, and atherosclerotic cardiovascular diseases.
Basic objectives2 Others
Basic objectives -Others The aim of this study is to determine the clinical significance of adipose-derived inflammatory mediators as a novel biological marker of metabolic dysregulation associated with obesity.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes inflammatory mediators: IL-6, IL-10, TNF-alpha, MCP-1, leptin, adiponectin, hs-CRP, PPARgamma, Mincle, Thrombospondin 1 (THBS1/TSP-1)
Key secondary outcomes body weight, waist circumference, BMI, blood pressure, HbA1c, FPG, TG, LDL-C, HDL-C, UA, BUN, Cre, visceral fat area, subcutaneous fat area

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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Outpatients undergoing surgery in the following areas: general surgery, plastic surgery, and urological surgery.
2) Patients who are able to attend the hospital
3) Age: 20 years of age and older, and below 80 years old
4) Patients providing written informed consent
Key exclusion criteria 1) Patients with severe renal and liver dysfunction
2) Patients with systemic inflammation
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriko Satoh-Asahara
Organization National Hospital Organization,
Kyoto Medical Center
Division name Clinical Research Institute
Zip code
Address 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto
TEL 075-645-9161
Email nsato@kyotolan.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Satoh-Asahara
Organization National Hospital Organization, Kyoto Medical Center
Division name Clinical Research Institute
Zip code
Address 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto
TEL 075-641-9161
Homepage URL
Email nsato@kyotolan.hosp.go.jp

Sponsor
Institute National Hospital Organization,
Kyoto Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization,
Kyoto Medical Center
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
2015 Year 03 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 No longer recruiting
Date of protocol fixation
2011 Year 02 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The expression levels of a series of inflammatory mediators (see Primary outcomes) will be quantified in human adipose tissues obtained from surgical patients by real-time PCR, and the protein levels in tissues and blood samples will be determined by ELISA. Human monocyte fractions will be isolated from the peripheral blood by MACS and subjected to the measurement of gene expression of the inflammatory mediators. These studies will reveal fat depot-specific characteristics of subcutaneous and visceral adipose tissue, and their relation to obesity traits, glucose and lipid metabolism, function of circulating monocytes, genetic variations associated with obesity, and postoperative prognosis.

Management information
Registered date
2015 Year 03 Month 17 Day
Last modified on
2015 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019514

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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