UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of relationship between severity of atopic dermatitis in adults and the degree of risk factors for metabolic syndrome
Title of the study (Brief title)	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	HIROYUKI MUROTA
Organization	Osaka university
Division name	Dept. of dermatology
Address	2-2, Yamadaoka, Suita, Osaka
TEL	06678795111
Email	h-murota@derma.med.osaka-u.ac.jp

Public contact
Name of contact person	0668795111
Organization	Osaka unversity
Division name	Dermatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000005106