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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000048094
Receipt No. 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

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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
Email 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
Email tkawai@keio.jp

Sponsor
Institute Tokyo Saiseikai Central Hospital
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054815

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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