UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048094 |
|---|---|
| Receipt number | R000054815 |
| Scientific Title | Effects of physical activity (radio calisthenics plus walking) on lowering blood glucose levels in Japanese patients with type 2 diabetes: an observational study |
| Date of disclosure of the study information | 2022/06/17 |
| Last modified on | 2022/06/17 20:23:32 |
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Basic information
Public title
Effects of physical activity (radio calisthenics plus walking) on lowering blood glucose levels in Japanese patients with type 2 diabetes: an observational study
Acronym
Effects of physical activity (radio calisthenics plus walking) on lowering blood glucose levels in Japanese patients with type 2 diabetes: an observational study
Scientific Title
Effects of physical activity (radio calisthenics plus walking) on lowering blood glucose levels in Japanese patients with type 2 diabetes: an observational study
Scientific Title:Acronym
Effects of physical activity (radio calisthenics plus walking) on lowering blood glucose levels in Japanese patients with type 2 diabetes: an observational study
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate the effects of physical activity (PA) on blood glucose (BG) levels compared to that of sedentary condition in individuals with type 2 diabetes mellitus (T2DM), participating in a diabetes educational hospitalization program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of blood glucose before lunch
Key secondary outcomes
Comparison between insulin (INS) and/or INS secretagogues and non of them.
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
| 25 | years-old | < |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes mellitus (T2DM) who were participating in a diabetes educational hospitalization program.
glycosylated hemoglobin (HbA1c) levels > 6.0 and < 13.0%;fasting plasma glucose levels > 70 and < 300 mg/dL to prevent hypoglycemia, ketoacidosis.
Key exclusion criteria
type 1 DM
known physical activity contraindications, including a recent history of a cardiovascular disease (acute myocardial infarction and cerebrovascular events within 6 months, unstable angina), symptoms of cardiac failure, or active bleeding; and physical problems limiting the ability to perform radio calisthenics and walking.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshihide |
| Middle name | |
| Last name | Kawai |
Organization
Tokyo Saiseikai Central Hospital
Division name
Internal Medicine
Zip code
108-0073
Address
1-4-17 Mita, Minato-ku, Tokyo
TEL
03-3451-8211
tkawai@keio.jp
Public contact
Name of contact person
| 1st name | Toshihide |
| Middle name | |
| Last name | Kawai |
Organization
Tokyo Saiseikai Central Hospital
Division name
Internal medicine
Zip code
108-0073
Address
1-4-17 Mita, Minato-ku, Tokyo
TEL
03-3451-8211
Homepage URL
https://www.saichu.jp
tkawai@keio.jp
Sponsor or person
Institute
Tokyo Saiseikai Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Saiseikai Central Hospital
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
Research Ethics Board, Tokyo Saiseikai Central Hospital
Address
1-4-17 Mita, Minato-ku, Tokyo
Tel
03-3451-8211
tikenjimu@saichu.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2021-031-1
Org. issuing International ID_1
Tokyo Saiseikai Central Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 17 | 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
105
Results
On the PA day, mean BG levels before breakfast and before lunch were 134.1 and 152.0 mg/dL, respectively, whereas on the CL day, the corresponding values were 136.9 and 165.8 mg/dL. A significant difference was observed between the before-lunch BG levels on both days.
Results date posted
| 2022 | Year | 06 | Month | 17 | Day |
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
| 2021 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 14 | Day |
Date analysis concluded
| 2022 | Year | 05 | Month | 14 | Day |
Other
Other related information
All participants were adherent to the program.
Management information
Registered date
| 2022 | Year | 06 | Month | 17 | Day |
Last modified on
| 2022 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054815
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| Registered date | File name |
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| Registered date | File name |
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