UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040445 |
|---|---|
| Receipt number | R000046161 |
| Scientific Title | Usefulness of Interval walking training in patients with type 2 diabetes after 1 year |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2021/05/31 18:23:39 |
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Basic information
Public title
Usefulness of Interval walking training in patients with type 2 diabetes after 1 year
Acronym
IWT in T2DM after 1 year
Scientific Title
Usefulness of Interval walking training in patients with type 2 diabetes after 1 year
Scientific Title:Acronym
IWT in T2DM after 1 year
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
HbA1c change rate after 52 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c change rate after 52 weeks.
Key secondary outcomes
Body composition change rate after 52 weeks.
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Instruct to Interval walking training at least 4 times a week for 52 weeks.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
HbA1c 6.5 to 10.0% and BMI 22 to 34.
Key exclusion criteria
Pre-proliferative diabetic retinopathy and Proliferative diabetic retinopathy.
Diabetic nephropathy more than stage 3.
History of stroke and coronary artery disease.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | kohei |
| Middle name | |
| Last name | kitajima |
Organization
Shinshu University Hospital
Division name
Diabetes Endocrinology
Zip code
390-0802
Address
Nagano pre,Matsumoto city,asahi 3-1-1
TEL
0263-35-4600
kitajima@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | kohei |
| Middle name | |
| Last name | kitajima |
Organization
Shinshu University Hospital
Division name
Diabetes Endocrinology
Zip code
390-0802
Address
Nagano pre,Matsumoto city,asahi 3-1-1
TEL
0263-35-4600
Homepage URL
kitajima@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Hospital
Institute
Department
Personal name
Funding Source
Organization
non
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
Shinshu University Hospital
Address
Nagano pre,Matsumoto city,asahi 3-1-1
Tel
0263-35-4600
kitajima@shinshu-u.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 | 07 | Month | 01 | 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
47
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 05 | Month | 19 | Day |
Last modified on
| 2021 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046161
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
