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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039603
Receipt No. R000045162
Scientific Title Relationship of daily hot water bathing at home with glycemic control in middle-aged and elderly ambulatory patients with type 2 diabetes mellitus: a Japanese multicenter cross-sectional study
Date of disclosure of the study information 2020/03/01
Last modified on 2021/09/21

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Basic information
Public title Relationship of daily hot water bathing at home with glycemic control in middle-aged and elderly ambulatory patients with type 2 diabetes mellitus
Acronym Relationship between daily hot water bathing and glycemic control
Scientific Title Relationship of daily hot water bathing at home with glycemic control in middle-aged and elderly ambulatory patients with type 2 diabetes mellitus: a Japanese multicenter cross-sectional study
Scientific Title:Acronym Relationship between daily hot water bathing and glycemic control
Region
Japan

Condition
Condition Middle-aged and elderly ambulatory patients with type 2 diabetes mellitus (T2DM)
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationship between daily hot water bathing (HWB) at home and glycemic control in middle-aged and elderly ambulatory patients with T2DM.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c
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
40 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Ambulatory patients aged 40-75 years with T2DM
Key exclusion criteria People with certification for long-term care or who are hospitalized are excluded.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Hiroharu
Middle name
Last name Kamioka
Organization Tokyo University of Agriculture
Division name Faculty of Environment Science
Zip code 156-8502
Address Sakuragaoka 1-1-1, Setagaya-ku, Tokyo
TEL 03-5477-2587
Email h1kamiok@nodai.ac.jp

Public contact
Name of contact person
1st name Toshiki
Middle name
Last name Tanaka
Organization Tokyo University of Agriculture
Division name Research Institute
Zip code 156-8502
Address Sakuragaoka 1-1-1, Setagaya-ku, Tokyo
TEL 03-5477-2532
Homepage URL
Email t3tanaka@nodai.ac.jp

Sponsor
Institute Academic Committee, Japanese Society of Balneology, Climatology and Physical Medicine
Institute
Department

Funding Source
Organization Japanese Society of Balneology, Climatology and Physical Medicine
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 IRB in Tokyo University of Agriculture
Address Sakuragaoka 1-1-1, Setagaya-ku, Tokyo
Tel 03-5477-2532
Email t3tanaka@nodai.ac.jp

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
2020 Year 03 Month 01 Day

Related information
URL releasing protocol https:// upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000045162
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7764630/pdf/dmso-13-5059.pdf
Number of participants that the trial has enrolled 838
Results A higher frequency of HWB was moderately associated with a decreased risk of poor glycemic control in middle-aged and elderly ambulatory patients with T2DM. Please refer to the published article.
Results date posted
2021 Year 09 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics There was a significant difference (p<0.001) in age between males (n=528, 62.8 years) and females (n=310, 65.0 years) in this study. Regarding HbA1c levels, there was no significant difference between males (7.1%) and females (6.8%). There was a significant difference (p<0.05) between males (12.6 years) and
females (11.2 years) in T2DM duration.
Participant flow Of 970 potential ambulatory patients, 863 were interviewed for the study while 107 declined. After excluding 25 patients with missing data, a total of 838 patients (86.4%) had data that was valid for analysis.
Adverse events nothing.
Outcome measures HbA1c.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2020 Year 02 Month 01 Day
Date of IRB
2020 Year 02 Month 14 Day
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2020 Year 06 Month 14 Day
Date of closure to data entry
2020 Year 07 Month 10 Day
Date trial data considered complete
2020 Year 07 Month 20 Day
Date analysis concluded
2020 Year 07 Month 31 Day

Other
Other related information Study member:
Prof. Hiroharu Kamioka, Prof. Takahiko Horiuchi, Dr. Yasunori Mori, Prof. Takahito Hayashi, Dr. Koichiro Ohmura, Dr. Satoshi Yamaguchi, Dr. Mitsutoshi Katoh
Definition of daily hot water bathing at home (HWB):
We defines daily HWB as taking a bath to soak in the bathtub, regardless of whether normal tap water or hot spring water is used.
Primary explanatory variables:
We set frequency and time in daily HWB as explanatory variables along with HbA1c. This information is recorded by the doctors conducting interviews.
Covariates:
The doctors check sex, age, height, weight, BMI, T2DM duration, alcohol consumption status, meal modification status, smoking status, exercise status on the questionnaire sheet. Based on medical record, the doctors transcribe the patient's oral and injection medications into the sheet. In addition, the presence of sick days and dizziness and impaired consciousness associated with hypoglycemia are also examined.

Management information
Registered date
2020 Year 02 Month 26 Day
Last modified on
2021 Year 09 Month 21 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045162

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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