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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024757
Receipt No. R000028481
Scientific Title Glycemic Control in Diabetic Patients Following the Kumamoto Earthquake 2016.
Date of disclosure of the study information 2016/11/22
Last modified on 2018/01/07

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Basic information
Public title Glycemic Control in Diabetic Patients Following the Kumamoto Earthquake 2016.
Acronym Glycemic Control in Diabetes Following the Kumamoto Earthquake.
Scientific Title Glycemic Control in Diabetic Patients Following the Kumamoto Earthquake 2016.
Scientific Title:Acronym Glycemic Control in Diabetes Following the Kumamoto Earthquake.
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will investigate the effects of the Kumamoto Earthquake that took place on April 14th
and 16th 2016 on glycemic control in diabetic patients.
We will contribute to improve the quality of diabetic medical treatment at the time of devastating disasters.
Basic objectives2 Others
Basic objectives -Others In order to find the contributing factors to influence glycemic control in diabetes associated with earthquake.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c
Key secondary outcomes BW, BP, HR, blood glucose, GA, IRI, C-peptide, urinary albumin, AST, ALT, LDH, BUN, Cre, eGFR, UA, LDL-C, HDL-C, TG, TC, WBC, RBC, Hb, Plt, Ht

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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Diabetic patients who are regularly followed by Metabolic Medicine, Kumamoto University.
Key exclusion criteria Living outside from Kumamoto Prefecture. Gestational diabetes.
Target sample size 700

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Kondo
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Metabolic Medicine
Zip code
Address 1-1-1 Honjo, Chuo-Ward, Kumamoto City
TEL +81-96-373-5169
Email t-kondo@gpo.kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Kondo
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Metabolic Medicine
Zip code
Address 1-1-1 Honjo, Chuo-Ward, Kumamoto City
TEL +81-96-373-5169
Homepage URL
Email t-kondo@gpo.kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University
Institute
Department

Funding Source
Organization Kumamoto University
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
Address
Tel
Email

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
2016 Year 11 Month 22 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 Completed
Date of protocol fixation
2016 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
2018 Year 01 Month 07 Day
Date trial data considered complete
2018 Year 01 Month 07 Day
Date analysis concluded

Other
Other related information Questionnaire (suffer from earthquake, evacuation, spending the night in a car, medication, food supply, water, exercise, medical information, bereavement, mental stress IES-R(Impact of Event Scale-Revised) score) will be performed.

Management information
Registered date
2016 Year 11 Month 08 Day
Last modified on
2018 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028481

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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