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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028029
Receipt No. 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

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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
Email 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
Email tanishigem@yahoo.co.jp

Sponsor
Institute Nihon University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032095

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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