UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015690 |
|---|---|
| Receipt number | R000018237 |
| Scientific Title | The skin survey among patients with lifestyle-related diseases. |
| Date of disclosure of the study information | 2014/11/14 |
| Last modified on | 2017/05/16 14:31:11 |
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Basic information
Public title
The skin survey among patients with lifestyle-related diseases.
Acronym
The skin survey among patients with lifestyle-related diseases.
Scientific Title
The skin survey among patients with lifestyle-related diseases.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tomoko Akase |
Organization
Yokohama City University
Division name
Department of Biological Science and Nursing, Graduate School of Medicine
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, 236-004
TEL
045-787-2743
akase@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Akase |
Organization
Yokohama City University
Division name
Department of Biological Science and Nursing, Graduate School of Medicine
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, 236-004
TEL
045-787-2743
Homepage URL
akase@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of biological science and nursing, Graduate school of medicine, Yokohama city university
Institute
Department
Personal name
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)
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
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 |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2014 | Year | 11 | Month | 14 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018237
| Research Plan | |
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| 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 |
