UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050298 |
|---|---|
| Receipt number | R000057172 |
| Scientific Title | Verification of the effect of postprandial sedentary behavior instruction on improving blood glucose |
| Date of disclosure of the study information | 2023/02/13 |
| Last modified on | 2024/01/31 15:31:08 |
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Basic information
Public title
Verification of the effect of postprandial sedentary behavior instruction on improving blood glucose
Acronym
Verification of the effect of postprandial sedentary behavior instruction on improving blood glucose
Scientific Title
Verification of the effect of postprandial sedentary behavior instruction on improving blood glucose
Scientific Title:Acronym
Verification of the effect of postprandial sedentary behavior instruction on improving blood glucose
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effect of teaching sedentary behavior on improving blood glucose
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average weekly blood glucose levels assessed by CGM before and after sedentary instruction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Instruct the patient not to sit down for 30 minutes after eating
Interventions/Control_2
Instruct the patient to sit for 30 minutes after eating.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Is attending Ayabe City Hospital
Diagnosed with type 2 diabetes
HbA1c 6.5-9.5 %.
BMI: 18-40
Key exclusion criteria
Insulin deficiency, pregnant women, on dialysis, active retinopathy, severe autonomic neuropathy, severe proteinuria, and other conditions that are contraindications to exercise therapy.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Osaka |
Organization
Ayabe City Hospital
Division name
Department of Endocrinology and Diabetology
Zip code
623-0011
Address
20-1, Otsuka, Aono-cho, Ayabe, Kyoto 623-0011, Japan
TEL
0773-43-0123
tak-1314@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Osaka |
Organization
Ayabe City Hospital
Division name
Department of Endocrinology and Diabetology
Zip code
623-0011
Address
20-1, Otsuka, Aono-cho, Ayabe, Kyoto 623-0011, Japan
TEL
0773-43-0123
Homepage URL
tak-1314@koto.kpu-m.ac.jp
Sponsor or person
Institute
Ayabe City Hospital
Institute
Department
Personal name
Funding Source
Organization
non
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
Ayabe City Hospital
Address
20-1, Otsuka, Aono-cho, Ayabe, Kyoto 623-0011, Japan
Tel
09051289039
tak-1314@koto.kpu-m.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
綾部市立病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057172
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
