UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Glycemic Control in Diabetic Patients Following the Kumamoto Earthquake 2016.
Title of the study (Brief title)	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	Tatsuya Kondo
Organization	Faculty of Life Sciences, Kumamoto University
Division name	Department of Metabolic Medicine
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	Tatsuya Kondo
Organization	Faculty of Life Sciences, Kumamoto University
Division name	Department of Metabolic Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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