UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039603 |
|---|---|
| Receipt number | 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 09:40:08 |
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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
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
t3tanaka@nodai.ac.jp
Sponsor or person
Institute
Academic Committee, Japanese Society of Balneology, Climatology and Physical Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045162
| 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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