UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023387 |
|---|---|
| Receipt number | R000026948 |
| Scientific Title | Glycemic Control in Diabetic Patients Following the Kumamoto Earthquake 2016 |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2018/07/31 13:55:10 |
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Basic information
Public title
Glycemic Control in Diabetic Patients Following the Kumamoto Earthquake 2016
Acronym
Glycemic Control on Kumamoto Earthquake 2016
Scientific Title
Glycemic Control in Diabetic Patients Following the Kumamoto Earthquake 2016
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tatsuya Kondo |
Organization
Kumamoto University
Division name
Department of Metabolic Medicine, Faculty of Life Sciences.
Zip code
Address
1-1-1 Honjo, Chuo-Ward. Kumamoto.
TEL
096-373-5169
t-kondo@gpo.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Kondo |
Organization
Kumamoto University
Division name
Department of Metabolic Medicine, Faculty of Life Sciences.
Zip code
Address
1-1-1 Honjo, Chuo-Ward. Kumamoto.
TEL
096-373-5169
Homepage URL
t-kondo@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University, Department of Metabolic Medicine, Faculty of Life Sciences.
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/abs/10.1111/jdi.12891
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/abs/10.1111/jdi.12891
Number of participants that the trial has enrolled
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.
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
Main results already published
Date of protocol fixation
| 2016 | Year | 07 | Month | 06 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026948
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
