UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028029 |
|---|---|
| Receipt number | R000032095 |
| Scientific Title | Impact of LDL-particle Size in Coronary Artery Disease Patients with Type 2 Diabetes |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2018/12/10 06:52:23 |
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Basic information
Public title
Impact of LDL-particle Size in Coronary Artery Disease Patients with Type 2 Diabetes
Acronym
Evaluation of DM and estimated LDL-particle size
Scientific Title
Impact of LDL-particle Size in Coronary Artery Disease Patients with Type 2 Diabetes
Scientific Title:Acronym
Evaluation of DM and estimated LDL-particle size
Region
| Japan |
Condition
Condition
Consecutive outpatients with the presence of one or more risk factors for atherosclerosis
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the LDL-C/apoB ratio as a marker of LDL-particle size in CAD patients with DM in a hospital-based cross-sectional/longitudinal study, and to assess LDL-particle size in relation to TG metabolism using TRL-related markers (TG, very LDL [VLDL], remnant-like particle cholesterol [RLP-C], apolipoprotein (apo) C-II, and apo C-III) as indicators.
Basic objectives2
Others
Basic objectives -Others
In addition, we examined the relationships among the changes in the LDL-C/apoB ratio and changes in the TRL-related markers in those cases that were still available for additional measurements 6 months later.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Relatioship between coronary artery disease patient with type 2 diabetes and LDL particle size.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The study was conducted on a sample of
700 consecutive outpatients with the
presence of one or more risk factors for
CAD, who had undergone regular examinations for treatment of their various disease
at the Cardiovascular Center, Nihon University Surugadai Hospital between April 2009 and October 2009.
Key exclusion criteria
Patients were not enrolled if they met
any of the following exclusion criteria:
hepatic dysfunction, known malignant disease, or diagnosis of acute coronary
syndrome within 3 months prior to the
study.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigemasa Tani |
Organization
Nihon University Hospital
Division name
Department of Cardiology
Zip code
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo , Japan
TEL
03-3293-1711
tanishigem@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigemasa Tani |
Organization
Nihon University Hospital
Division name
Department of Cardiology
Zip code
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo , Japan
TEL
03-3293-1711
Homepage URL
tanishigem@yahoo.co.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Nihon University 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
| 2017 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2009 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | 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
This study is cross-sectional sudy.
The study was conducted on a sample of 700 consecutive outpatients with the presence of one or more risk factors for CAD, who had undergone regular examinations for treatment of their various disease at the Cardiovascular Center, Nihon University Surugadai Hospital between April 2009 and October 2009.
Management information
Registered date
| 2017 | Year | 07 | Month | 01 | Day |
Last modified on
| 2018 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032095
