UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009039 |
|---|---|
| Receipt number | R000010609 |
| Scientific Title | Predictive value of carotid intima media thickness for cardiovascular disease in type 2 diabetic patients |
| Date of disclosure of the study information | 2012/10/04 |
| Last modified on | 2019/04/11 08:44:36 |
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Basic information
Public title
Predictive value of carotid intima media thickness for cardiovascular disease in type 2 diabetic patients
Acronym
IMT and CVD
Scientific Title
Predictive value of carotid intima media thickness for cardiovascular disease in type 2 diabetic patients
Scientific Title:Acronym
IMT and CVD
Region
| Japan |
Condition
Condition
type 2 diabetic patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this retrospective study was to investigate the relationship between surrogate makerand cardiovascular events in Japanese type 2 diabetics.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
predictive value ofcarotid IMT for CVD events
Key secondary outcomes
predictive value ofcarotid baPWV and ABI for CVD events
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes who had their cIMT assessed at the outpatient clinic of Juntendo University Hospital between 2003 and 2005 were recruited in a cohort study. Patients fitting the following criteria were selected for this study: 1) 30-75 years of age, 2) negative history of CVD.
Key exclusion criteria
severe renal dysfunction,
severe liver disease,
malignancy
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Mita |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism and Endocrinology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku
TEL
03-3813-3111
tom-m@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Mita |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism and Endocrinology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421
TEL
03-3813-3111
Homepage URL
tom-m@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Graduate School of Medicine
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
Juntendo Ethics Committee
Address
Hongo2-1-1, Bunkyo, Tokyo
Tel
0338133111
kenkyu5858@juntendo.ac.jp
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
| 2012 | Year | 10 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
CV events were extracted from the medical records
Management information
Registered date
| 2012 | Year | 10 | Month | 04 | Day |
Last modified on
| 2019 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010609
