UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038741 |
|---|---|
| Receipt number | R000044170 |
| Scientific Title | The effect on glycemic controls of social avtivity among patients with type 2 diabetes (T2D)in a year after hospitalization |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2021/07/05 00:24:55 |
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Basic information
Public title
The effect on glycemic controls of social avtivity among patients with type 2 diabetes (T2D)in a year after hospitalization
Acronym
The effect on glycemic controls of social avtivity among patients with type 2 diabetes (T2D)in a year after hospitalization
Scientific Title
The effect on glycemic controls of social avtivity among patients with type 2 diabetes (T2D)in a year after hospitalization
Scientific Title:Acronym
The effect on glycemic controls of social avtivity among patients with type 2 diabetes (T2D)in a year after hospitalization
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare HbA1c level one year later hospitalization inelderly diabetes patients with social paticipation to without it.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will investigate the differences of HbA1c levels between T2D patients with social participation and those without it,the HbA1c levels are assessed in a year after hospitalization.
Key secondary outcomes
We will investigate the differences of body weights between T2D patients with social participation and those without it,the body weights are assessed in a year after hospitalization.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Aged 65 years or older patient with type 2 diabetes in-Hospital Diabetes Educational Program.
Key exclusion criteria
Diabeic ketoacidosis
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Minami |
Organization
Saiseikai Yokohama shi Nanbu Hospital
Division name
Diabetes and Endocrinology
Zip code
234-0054
Address
3-2-10,Konandai Konan-ku,Yokohama-shi,Kanagawa 234-0054 Japan
TEL
0458321111
ksqdd034@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mayuko |
| Middle name | |
| Last name | Takahashi |
Organization
Saiseikai Yokohama shi Nanbu Hospital
Division name
Diabetes and Endocrinology
Zip code
234-0054
Address
3-2-10,Konandai Konan-ku,Yokohama-shi,Kanagawa 234-0054 Japan
TEL
0458321111
Homepage URL
kanagawa0320@gmail.com
Sponsor or person
Institute
Saiseikai Yokohama shi Nanbu Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Saiseikai Yokohama shi Nanbu Hospital
Address
3-2-10,Konandai Konan-ku,Yokohama-shi,Kanagawa 234-0054 Japan
Tel
0458321111
soumu01@nanbu.saiseikai.or.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
| 2019 | Year | 12 | 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
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
| 2019 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 12 | 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
This is a prospective cohort study.We will investigate the differences of HbA1c levels between T2D patients with social participation and those withoutit,the HbA1c levels are assessed in a year after hospitalization.
Management information
Registered date
| 2019 | Year | 11 | Month | 29 | Day |
Last modified on
| 2021 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044170
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
