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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032934
Receipt No. R000037545
Official scientific title of the study Association of the Serum Triglyceride/high-density Lipoprotein Cholesterol Ratio with Low-density Lipoprotein Heterogeneity: A Pilot Cross-sectional and Longitudinal Study
Date of disclosure of the study information 2018/06/11
Last modified on 2018/06/09

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Basic information
Official scientific title of the study Association of the Serum Triglyceride/high-density Lipoprotein Cholesterol Ratio with Low-density Lipoprotein Heterogeneity: A Pilot Cross-sectional and Longitudinal Study
Title of the study (Brief title) TG/HDL ratio and LDL heterogeneity
Region
Japan

Condition
Condition patients with one additional risk factor for atherosclerosis.
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study was designed as a hospital-based cross-sectional and longitudinal study to investigate the relationships between the serum TG/HDL-C ratio and LDL-heterogeneity, as assessed by polyacrylamide-gel electrophoresis (PAGE), in patients with one or more risk factors for ACVD. Furthermore, we examined the relationship between the changes in the TG/HDL-C ratio and the change in the LDL particle size in cases in which additional measurements could also be conducted 1 year later.
Basic objectives2 Others
Basic objectives -Others A receiver-operating characteristic analysis was performed to determine the cutoff value of the TG/HDL-C ratio for LDL-Rm values>0.40.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1)the relationships between the serum TG/HDL-C ratio and LDL-heterogeneity, as assessed by polyacrylamide-gel electrophoresis (PAGE)in patients with one or more risk factors for ACVD.
2)Furthermore, we examined the relationship between the changes in the TG/HDL-C ratio and the change in the LDL particle size in cases in which additional measurements could also be conducted 1 year later.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria The criterion for patient registration in the cross sectional study was the presence of one or more risk factors for atherosclerosis.
Key exclusion criteria Patients were not enrolled if they met any of the following exclusion criteria: presence of hepatic dysfunction (serum alanine aminotransferase and aspartate aminotransferase levels 2 times the upper limit of normal),known malignant disease, diagnosis of acute coronary syndrome within 3 months prior to the study, and/or serum TG 400 mg/dL.
Target sample size 700

Research contact person
Name of lead principal investigator Shigemasa Tani
Organization Nihon University Hospital
Division name Health Plannning Center
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 Health Planning Center
Address 1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo , Japan
TEL 03-3293-1711
Homepage URL
Email tanishigem@yahoo.co.jp

Sponsor
Institute Department of Health Planning Center, Nihon-University Hospital
Institute
Department

Funding Source
Organization Department of Health Planning Center, 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
2018 Year 06 Month 11 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2009 Year 04 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 Unpublished
URL releasing results
Results
Other related information This study was designed as a hospital-based cross-sectional and longitudinal study to investigate the relationships between the serum TG/HDL-C ratio and LDL-heterogeneity, as assessed by polyacrylamide-gel electrophoresis (PAGE), in patients with one or more risk factors for ACVD. Furthermore, we examined the relationship between the changes in the TG/HDL-C ratio and the change in the LDL particle size in cases in which additional measurements could also be conducted 1 year later.

Management information
Registered date
2018 Year 06 Month 09 Day
Last modified on
2018 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037545

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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