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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037553
Receipt No. 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 2019/07/31

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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
Email 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
Email daiki.k.0723@gmail.com

Sponsor
Institute Iwate Medical University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2019 Year 07 Month 31 Day
Date of IRB
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
2019 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042817

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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