UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The skin survey among patients with lifestyle-related diseases.
Title of the study (Brief title)	The skin survey among patients with lifestyle-related diseases.
Region	Japan

Condition
Condition	Lifestyle-related diseases (obesity, impaired glucose tolerance, hypertension, hyperlipidemia)
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish nursing care for prevention of skin complications caused by obesity is the aim of this study.
Basic objectives2	Others
Basic objectives -Others	To confirm skin complications caused by obesity.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Subcutaneous abnormality (scar-like lesion, follicular papule, regional hair loss caused by friction, pigmentation, papillary lesion, eczematous rash, dry skin, desquamation)
Key secondary outcomes	Percent of body fat, Percent of subcutaneous fat, Biochemical examination (blood glucose level, HbA1c, triglyceride, total cholesterol, high-density lipoprotein, low-density lipoprotein), skin-moisture measurement, subjective symptomatic state

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Skin-moisture measurement using moisture meter
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Outpatients with lifestyle-related diseases(i.e.obesity,impaired glucose tolerance,hypertension,hyperlipidemia)in Yokohama City University Hospital.
Key exclusion criteria	Not applicable
Target sample size	100

Research contact person
Name of lead principal investigator	Tomoko Akase
Organization	Yokohama City University
Division name	Department of Biological Science and Nursing, Graduate School of Medicine
Address	3-9, Fukuura, Kanazawa-ku, Yokohama, 236-004
TEL	045-787-2743
Email	akase@yokohama-cu.ac.jp

Public contact
Name of contact person	Tomoko Akase
Organization	Yokohama City University
Division name	Department of Biological Science and Nursing, Graduate School of Medicine
Address	3-9, Fukuura, Kanazawa-ku, Yokohama, 236-004
TEL	045-787-2743
Homepage URL
Email	akase@yokohama-cu.ac.jp

Sponsor
Institute	Department of biological science and nursing, Graduate school of medicine, Yokohama city university
Institute
Department

Funding Source
Organization	Yokohama City University
Organization
Division
Category of Funding Organization	Other
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	横浜市立大学附属病院（神奈川県）Yokohama City University Hospital（Kanagawa Prefecture）

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 14 Day
Anticipated trial start date	2014 Year 11 Month 14 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 11 Month 14 Day
Last modified on	2017 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018237