UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of LDL-particle Size in Coronary Artery Disease Patients with Type 2 Diabetes
Title of the study (Brief title)	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	Shigemasa Tani
Organization	Nihon University Hospital
Division name	Department of Cardiology
Address	1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo , Japan
TEL	03-3293-1711
Email	tanishigem@yahoo.co.jp

Public contact
Name of contact person	Shigemasa Tani
Organization	Nihon University Hospital
Division name	Department of Cardiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000032095