UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004285 |
|---|---|
| Receipt number | R000005106 |
| Scientific Title | Verification of relationship between severity of atopic dermatitis in adults and the degree of risk factors for metabolic syndrome |
| Date of disclosure of the study information | 2010/09/28 |
| Last modified on | 2018/12/31 09:17:31 |
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Basic information
Public title
Verification of relationship between severity of atopic dermatitis in adults and the degree of risk factors for metabolic syndrome
Acronym
Relationship between skin diseases and marker for metabolic syndrome
Scientific Title
Verification of relationship between severity of atopic dermatitis in adults and the degree of risk factors for metabolic syndrome
Scientific Title:Acronym
Relationship between skin diseases and marker for metabolic syndrome
Region
| Japan |
Condition
Condition
atopic dermatitis, psoriasis, healthy volunteer
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The relation between obesity and asthma has often been pointed out, most notably association between body-mass index (BMI) and incidence of asthma in childhood. However, there have been few reports, which focused on the research into the connection between risk factors for metabolic syndrome and atopic dermatitis (AD) in older patients. We had conducted this study for the purpose of evaluating the relation between metabolic balance and adult case with AD and psoriasis.
Basic objectives2
Others
Basic objectives -Others
observation test
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To validate this relevance, risk factors such as body fat percentage, BMI, blood cholesterol level, blood triglyceride level, and blood adipokine level were measured, and were compared with the disease severity (SCORAD) or serum concentration of IgE.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Data were corrected from the patients with comprehensive consent (since April, 2007).
1) Confirmed diagnosis of atopic dermatitis with both Japanese, and Hanifin&Rajka criteria.
2) Patients with psoriasis who are diagnosed by the characteristic findings
3) Healthy volunteers
Key exclusion criteria
Patients with no comprehensive consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIROYUKI MUROTA |
Organization
Osaka university
Division name
Dept. of dermatology
Zip code
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06678795111
h-murota@derma.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | 0668795111 |
Organization
Osaka unversity
Division name
Dermatology
Zip code
Address
2-2suita
TEL
0668795111
Homepage URL
h-murota@derma.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka univeristy
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2010 | Year | 09 | Month | 28 | 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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The certain data of the first medical examination has been collected retrospectively, and the statistical analysis will be done.
Management information
Registered date
| 2010 | Year | 09 | Month | 28 | Day |
Last modified on
| 2018 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005106
