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 on Kumamoto Earthquake 2016
Region	Japan

Condition
Condition	Diabetes Mellitus
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.
Basic objectives2	Others
Basic objectives -Others	We will contribute to improve the quality of diabetic medical treatment at the time of devastating disasters.
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c 1, 3, 6 and 12 months after the Earthequakes.
Key secondary outcomes	Glycated albumin, insulin, C peptide, urinary albumin excretion.

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	15 years-old <=
Age-upper limit	99 years-old >
Gender	Male and Female
Key inclusion criteria	Diabetes Mellitus
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	Kumamoto University
Division name	Department of Metabolic Medicine, Faculty of Life Sciences.
Address	1-1-1 Honjo, Chuo-Ward. Kumamoto.
TEL	096-373-5169
Email	t-kondo@gpo.kumamoto-u.ac.jp

Public contact
Name of contact person	Tatsuya Kondo
Organization	Kumamoto University
Division name	Department of Metabolic Medicine, Faculty of Life Sciences.
Address	1-1-1 Honjo, Chuo-Ward. Kumamoto.
TEL	096-373-5169
Homepage URL
Email	t-kondo@gpo.kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University, Department of Metabolic Medicine, Faculty of Life Sciences.
Institute
Department

Funding Source
Organization	Kumamoto University, Department of Metabolic Medicine, Faculty of Life Sciences.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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 08 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 07 Month 06 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	https://onlinelibrary.wiley.com/doi/abs/10.1111/jdi.12891
Publication of results	Published
URL releasing results	https://onlinelibrary.wiley.com/doi/abs/10.1111/jdi.12891
Results	A total of 557 patients were enrolled and data were collected from 13 months before to 13 months after the earthquakes. In patients with type 1 diabetes (T1D) or specific types of diabetes due to other causes, glycemic control was not altered during the observational period. This glycemic stability in T1D may result from self-management of insulin doses (increase in 7% and decrease in 20% of patients). In patients with type 2 diabetes (T2D), HbA1c was decreased by 0.11% (from 7.33% to 7.22%) at 1-2 months after the earthquakes compared to that before the earthquakes, and increased thereafter.
Other related information	We will collect the patient's information and data using questionnaire of IES-R (Impact of Event Scale-Revised).

Management information
Registered date	2016 Year 07 Month 29 Day
Last modified on	2018 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026948