UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037553 |
|---|---|
| Receipt number | R000042817 |
| Scientific Title | Development of prevention program using community based participatory approach to seasonal variation of HbA1c levels in patients with diabetes mellitus |
| Date of disclosure of the study information | 2019/07/31 |
| Last modified on | 2022/01/31 13:56:01 |
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Basic information
Public title
Development of prevention program using community based participatory approach to seasonal variation of HbA1c levels in patients with diabetes mellitus
Acronym
Development of prevention program using community based participatory approach to seasonal variation of HbA1c levels in patients with diabetes mellitus
Scientific Title
Development of prevention program using community based participatory approach to seasonal variation of HbA1c levels in patients with diabetes mellitus
Scientific Title:Acronym
Development of prevention program using community based participatory approach to seasonal variation of HbA1c levels in patients with diabetes mellitus
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To confirm the seasonal variation of HbA1c levels in patients with diabetes mellitus in a retrospective cohort and confirm whether the seasonal variation of HbA1c is related to social determinants of health.
2. Intervention of prevention program using community based participatory approach to seasonal variation of HbA1c, confirm seasonal variation of HbA1c.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c, cardiovascular disease, survival.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Nutrition therapy
Interventions/Control_2
No nutrition therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with diabetes mellitus
Key exclusion criteria
Cases without type 2 diabetes.
4 or more stage diabetic nephropathy or renal failure case equivalent to it.
Steroid treatment, case during chemotherapy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Daiki |
| Middle name | |
| Last name | Kikuchi |
Organization
Iwate Medical University
Division name
General medical department
Zip code
0208505
Address
19-1 Uchimaru Morioka city Iwate
TEL
0196515111
daiki.k.0723@gmail.com
Public contact
Name of contact person
| 1st name | Daiki |
| Middle name | |
| Last name | Kikuchi |
Organization
Iwate Medical University
Division name
General medical department
Zip code
0208505
Address
19-1 Uchimaru Morioka city Iwate
TEL
0196515111
Homepage URL
daiki.k.0723@gmail.com
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Iwate Medical University
Address
19-1 Uchimaru Morioka city Iwate
Tel
0196515111
daiki.k.0723@gmail.com
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 | 07 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 31 | Day |
Last modified on
| 2022 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042817
