UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014977 |
|---|---|
| Receipt number | R000014787 |
| Scientific Title | Evaluation of annual fluctuation of HbA1c of diabetes patients. |
| Date of disclosure of the study information | 2014/08/28 |
| Last modified on | 2018/08/31 10:59:31 |
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Basic information
Public title
Evaluation of annual fluctuation of HbA1c of diabetes patients.
Acronym
Evaluation of annual fluctuation of HbA1c of diabetes patients.
Scientific Title
Evaluation of annual fluctuation of HbA1c of diabetes patients.
Scientific Title:Acronym
Evaluation of annual fluctuation of HbA1c of diabetes patients.
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus (T2DM)
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We study the effect of the dietary intervention on the annual fluctuation of HbA1c of the type 2 diabetic patients as retrospective study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We divide T2DM patients into two groups, the dietary interventioned group and the non-dietary interventioned group, and compare the fluctuation of HbA1c.
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Outpatient with T2DM
Key exclusion criteria
Shedding of ambulatory
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taishi Aosa |
Organization
Inobe Hospital
Division name
Office of Nutrition
Zip code
Address
255, Nakao, Oita, OITA
TEL
097-586-5522
m12d9002@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taishi Aosa |
Organization
Inobe Hospital
Division name
Office of Nutrition
Zip code
Address
255, Nakao, Oita, OITA
TEL
097-586-5522
Homepage URL
m12d9002@oita-u.ac.jp
Sponsor or person
Institute
Inobe hospital
Institute
Department
Personal name
Funding Source
Organization
Inobe Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2014 | Year | 08 | Month | 28 | 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
| 2013 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
We finished the study.
Management information
Registered date
| 2014 | Year | 08 | Month | 28 | Day |
Last modified on
| 2018 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014787
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/08/31 | 臨床試験登録.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/08/31 | 臨床試験登録.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/08/31 | 臨床試験登録.pdf |
Single case data URL
Value
https://center6.umin.ac.jp/ice/14787
