UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024757
Receipt number 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 11:46:20

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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 or person

Institute

Kumamoto University

Institute

Department

Personal name



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

Value
https://center6.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