UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043008 |
|---|---|
| Receipt number | R000045973 |
| Scientific Title | Association between physical activity and glycemic control in type 1 diabetes |
| Date of disclosure of the study information | 2021/01/15 |
| Last modified on | 2024/01/22 15:57:18 |
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Basic information
Public title
Association between physical activity and glycemic control in type 1 diabetes
Acronym
Association between physical activity and glycemic control in type 1 diabetes
Scientific Title
Association between physical activity and glycemic control in type 1 diabetes
Scientific Title:Acronym
Association between physical activity and glycemic control in type 1 diabetes
Region
| Japan |
Condition
Condition
Type 1 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between physical activity and glycemic control in people with type 1 diabetes (cross-sectional and longitudinal study).
Basic objectives2
Others
Basic objectives -Others
To manage clinical condition in people with type 1 diabetes
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Term for evaluation
At baseline, at 1 year
Evaluation items
Glycemic control (HbA1c)
Key secondary outcomes
Term for evaluation
At baseline, at 1 year
Evaluation items
1. glycoalbumin (GA), blood glucose fluctuation
2. Blood lipids profile, body weight, body fat mass, waist circumference, blood pressure
3. Physical activity
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
| 20 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Outpatients with type 1 diabetes
Key exclusion criteria
1. Patients who have been diagnosed with diabetes for less than a year
2. Patients whose daily physical activities restricted by cardiovascular or motor dysfunction
3. Patients with severe chronic complications of diabetes.
4. Patients with cognitive decline
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Honda |
Organization
Shijonawate Gakuen University
Division name
Faculty of Rehabilitation
Zip code
574-0011
Address
5-11-10 Hojo, Daito, Osaka
TEL
072-863-5043
h-honda@un.shijonawate-gakuen.ac.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Honda |
Organization
Shijonawate Gakuen University
Division name
Faculty of Rehabilitation
Zip code
574-0011
Address
5-11-10 Hojo, Daito, Osaka
TEL
072-863-5043
Homepage URL
h-honda@un.shijonawate-gakuen.ac.jp
Sponsor or person
Institute
Shijonawate Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Japan Association for Diabetes Education and Care
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shijonawate Gakuen University
Address
5-11-10 Hojo, Daito, Osaka
Tel
072-863-5043
k-hanada@un.shijonawate-gakuen.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
神戸大学医学部附属病院（兵庫県）、兵庫県立姫路循環器病センター（兵庫県）、淀川キリスト教病院（大阪府）、神鋼記念病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | 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
126
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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to evaluate the association between physical activity and glycemic control in people with type 1 diabetes (cross-sectional and longitudinal study)
Management information
Registered date
| 2021 | Year | 01 | Month | 15 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045973
