UMIN-CTR Clinical Trial

Basic information
Public title	The effects of habits of bathing on metabolic parameters in patients with type 2 diabetes; a cross-sectional obserbvational study
Acronym	The effects of habits of bathing in patients with type 2 diabetes
Scientific Title	The effects of habits of bathing on metabolic parameters in patients with type 2 diabetes; a cross-sectional obserbvational study
Scientific Title:Acronym	The effects of habits of bathing in patients with type 2 diabetes
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the influences of habits of bathing on metabolic parameters in patients with type 2 diabetes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The correlations between the frequency of tub bathing and metabolic parameters
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with type 2 diabetes
Key exclusion criteria	Patients who can not answer the questionnaire or denies to answer
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hisayuki Katsuyama
Organization	National Center for Global Health and Medicine Kohnodai Hospital
Division name	Department of Internal Medicine
Zip code
Address	1-7-1 Kohnodai, Ichikawa-city, Chiba, Japan
TEL	+81-47-372-3501
Email	katsuyama-hs@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hisayuki Katsuyama
Organization	National Center for Global Health and Medicine Kohnodai Hospital
Division name	Department of Internal Medicine
Zip code
Address	1-7-1 Kohnodai, Ichikawa-city, Chiba, Japan
TEL	+81-47-372-3501
Homepage URL
Email	katsuyama-hs@umin.ac.jp

Sponsor
Institute	National Center for Global Health and Medicine Kohnodai Hospital
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	2019 Year 02 Month 19 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	2018 Year 09 Month 20 Day
Date of IRB	2018 Year 10 Month 05 Day
Anticipated trial start date	2018 Year 10 Month 20 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 06 Month 30 Day

Other
Other related information	This is a cross-sectional observational study. The patients with type 2 diabetes, who regularly come to the hospitals, will be enrolled. They answer the questionnaire focusing on the habits of bathing. The results are compared with metabolic parameters like body mas index, waist circumference, blood pressure, and the results from blood or urine test.

Management information
Registered date	2019 Year 02 Month 19 Day
Last modified on	2019 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040925