UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001969 |
|---|---|
| Receipt number | 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 10:03:34 |
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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
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
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002403
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
