UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017606 |
|---|---|
| Receipt number | R000020388 |
| Scientific Title | The association between glucose oscillationand calculated by ADRR and atherosclerosis in Japanese patients with diabetes |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2019/01/29 12:26:08 |
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Basic information
Public title
The association between glucose oscillationand calculated by ADRR and atherosclerosis in Japanese patients with diabetes
Acronym
ADRR and atherosclerosis
Scientific Title
The association between glucose oscillationand calculated by ADRR and atherosclerosis in Japanese patients with diabetes
Scientific Title:Acronym
ADRR and atherosclerosis
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the relationship between glucose oscillation calculated by ADRR and progression of atherosclerosis
Basic objectives2
Others
Basic objectives -Others
Patients' back ground contributing ADRR
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADRR
Cervical IMT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
SMBG
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Japanes patients with diabetes
Key exclusion criteria
1. patients who cannot perform SMBG
2. patients with severe renal failure and liver dysfunction
3. depression, alcoholic
4. cancer
5. patients taking steroids or interferon
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Yanase |
Organization
Fukuoka university, school of medicine
Division name
Endocrinology and Diabetes Mellitus
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka city, Fukuoka, Japan
TEL
092-801-1011
tyanase@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Nomiyama |
Organization
Fukuoka university, school of medicine
Division name
Endocrinology and Diabetes Mellitus
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka city, Fukuoka, Japan
TEL
092-801-1011
Homepage URL
tnomiyama@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka university, school of medicine, division of endocrinology and diabetes mellitus
Institute
Department
Personal name
Funding Source
Organization
Fukuoka university, school of medicine, division of endocrinology and diabetes mellitus
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
| 2015 | Year | 06 | Month | 01 | 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
| 2015 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 18 | Day |
Last modified on
| 2019 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020388
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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