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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001969
Receipt No. R000002403
Scientific Title A clinical study of sampling human adipose tissue to elucidate the pathophysiology of metabolic syndrome
Date of disclosure of the study information 2009/05/14
Last modified on 2009/05/14

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Basic information
Public title A clinical study of sampling human adipose tissue to elucidate the pathophysiology of metabolic syndrome
Acronym A clinical study of sampling human adipose tissue to elucidate the pathophysiology of metabolic syndrome
Scientific Title A clinical study of sampling human adipose tissue to elucidate the pathophysiology of metabolic syndrome
Scientific Title:Acronym A clinical study of sampling human adipose tissue to elucidate the pathophysiology of metabolic syndrome
Region
Japan

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

Objectives
Narrative objectives1 To assess the mRNA levels of genes related to the metabolic syndrome, 11beta-hydroxysteroid dehydrogenase, angiotensinogen, leptin, adiponectin, etc, in human adipose tissue and investigate the mechanism of metabolic syndrome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the mRNA levels of genes related to the metabolic syndrome, 11beta-hydroxysteroid dehydrogenase, angiotensinogen, leptin, adiponectin, etc, in human adipose tissue
adipocyte diameter in human adipose tissue
Key secondary outcomes

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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. patients admitted to Kyoto University Hospital
2. patients agreed to sign informed consent
Key exclusion criteria 1. patients who had received steroid drugs
2. patients who had received insulin therapy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shintaro Yasue
Organization Kyoto Universitu Hospital
Division name Division of Endocrinology and Metabolism
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3172
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Masuzaki
Organization Kyoto Universitu Hospital
Division name Division of Endocrinology and Metabolism
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3172
Homepage URL
Email

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Division of Endocrinology and Metabolism, Kyoto University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Plastic and Reconstructive Surgery, Kyoto University Hospital
Division of Diabetes, Digestive, and Kidney Diseases, Department of Clinical Molecular Medicine, Kobe University Hospital
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
2009 Year 05 Month 14 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
2004 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2004 Year 04 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The mRNA levels of genes related to the metabolic syndrome, 11 beta-hydroxysteroid dehydrogenase, angiotensinogen, leptin, adiponectin, etc, in human adipose tissue are estimated.
Adipocyte size is determined by a Beckman Coulter Multisizer III.

Management information
Registered date
2009 Year 05 Month 14 Day
Last modified on
2009 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002403

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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