UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016823 |
|---|---|
| Receipt number | 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 17:32:28 |
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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
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
nsato@kyotolan.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization,
Kyoto Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019514
