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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004285
Receipt No. 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

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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
Email 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
Email h-murota@derma.med.osaka-u.ac.jp

Sponsor
Institute Osaka univeristy
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005106

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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