UMIN-CTR Clinical Trial

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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