UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057509 |
|---|---|
| Receipt number | R000065697 |
| Scientific Title | Effect of Walking in Water on Postprandial Hyperglycemia and Blood Glucose Time in Range for Type 2 Diabetes Mellitus |
| Date of disclosure of the study information | 2025/04/15 |
| Last modified on | 2025/04/04 04:23:09 |
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Basic information
Public title
Effect of Walking in Water on Postprandial Hyperglycemia and Blood Glucose Time in Range for Type 2 Diabetes Mellitus
Acronym
Effects of walking in water on blood glucose variability for type 2 diabetes mellitus
Scientific Title
Effect of Walking in Water on Postprandial Hyperglycemia and Blood Glucose Time in Range for Type 2 Diabetes Mellitus
Scientific Title:Acronym
Effects of walking in water on blood glucose variability for type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
patients with type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate time in range using Continuous Glucose Monitoring during water walking and land walking, and to clarify the effects of hydrostatic pressure and other factors specific to water walking on blood glucose fluctuations after water walking and its fluctuations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time in range
Baseline, Day 1 after start, Day 4 after start
Key secondary outcomes
coefficient of variation, mean amplitude of glycemic excursions, Area over the glucose curve, blood pressure, pulse
Baseline, Day 1 after start, Day 4 after start
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Walking in the water after eating
Interventions/Control_2
Athletics treadmill walking after eating
Interventions/Control_3
No special physical activity (control)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons diagnosed with type 2 diabetes mellitus and admitted for diabetes education for the purpose of blood glucose control
Key exclusion criteria
Those who discontinue their educational hospitalization midway through for any reason
Those who have added or changed medications
Those with incontinence or skin infections
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Nishida |
Organization
School of Health Sciences at Narita, International University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
286-8686
Address
4-3 Kozunomori, Narita city, Chiba, Japan
TEL
0476-20-7717
yuusuken@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuki |
| Middle name | |
| Last name | Sekino |
Organization
International University of Health and Welfare Graduate School
Division name
Health and Welfare Sciences
Zip code
286-8686
Address
4-3 Kozunomori, Narita city, Chiba, Japan
TEL
0476-20-7701
Homepage URL
24s1077@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Tatsuki sekino
Funding Source
Organization
Not
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
Tokyo Akasaka District Ethics Review Committee
Address
4-1-26 Akasaka, Minato-ku, Tokyo
Tel
03-5574-3900
rinri-tky@iuhw.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
JA静岡厚生連 中伊豆温泉病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065697
