Relationship Between CETP Deficiency and Atherosclerosis in Patients With Hyperalphalipoproteinemia (INFINITY)

April 14, 2015 updated by: Osaka University

Investigation of Relationship Between Cholesteryl Ester Transfer Protein Deficiency and Carotid/Coronary Atherosclerosis in Patients With Hyperalphalipoproteinemia

The aim of this study is to determine whether high high density lipoprotein-cholesterol(HDL-C) level and low Cholesteryl Ester Transfer Protein(CETP) activity is atherogenic or not in subjects who received health checkups. We investigate the association between CETP activities and the severity of atherosclerosis assessed by intima-media thickness (IMT) and compare the atherogenic change between in subjects with high HDL-C level, low HDL-C level, high CETP activities and low CETP activities by examining the morbidity rate of atherogenic diseases, the rate of ischemic electrocardiography(ECG) change, Calc Score of artery from chest X-ray, Ankle Brachial Index/Pulse Wave Velocity and various serum atherogenic markers. And we also examine the correlation between normal lipid profile and concentration, activity and function of surface lipoprotein in subjects with variety of lipoprotein levels, including patients with hyper-LDL-cholesterolemia, hyper-HDL-cholesterolemia with low or no CETP activity, patients with high level of remnant cholesterol or hyperlipoproteinemia of apolipoprotein(Apo)B-48.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Japan
    • Osaka
      • Suita, Osaka, Japan, 565-0879
        • Recruiting
        • Osaka University Graduate School of Medicine
        • Contact:
        • Principal Investigator:
          • Shizuya Yamashita, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We will explain about this study with the attached leaflet to the male and female examinees at the age of 40 and above who undergo annual health check up at Hiraga General Hospital in Akita Prefecture and obtain written consent to participate in the study. The written consents will be stored. The participant information will be made anonymous with sequential ID numbers. However the comparative lists of each participant and ID number will be stored in the locked shelf in case of disclosure requests from participants in future. The above will be conducted at Hiraga hospital and the samples will be sent to and measured to collect data in Osaka University. The analysis of data will be done at Osaka University and Akita University.

Description

Inclusion criteria:

Subjects who are at the age of 40 and above and undergo annual health check in Omagari area including Daisen city and Yokote city and who provide written informed consent.

Exclusion criteria:

  1. Those who do not provide written informed consent.
  2. Those who are not able to take tests.
  3. Those who are regarded not adequate as subject of this study by their physicians.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference of Ischemic changes of ECG among subjects with low/high CETP mass/activity and HDL-C level
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Ischemic changes of ECG was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
participants will be followed for the duration of hospital stay（2 days）
Difference of Calc Score of Aorta by Chest X-ray among subjects with low/high CETP mass/activity and HDL-C level
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Calc Score of Aorta by Chest X-ray was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
participants will be followed for the duration of hospital stay（2 days）
Difference of Ankle Brachial Index (ABI) among subjects with low/high CETP mass/activity and HDL-C level
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Ankle Brachial Index (ABI) was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
participants will be followed for the duration of hospital stay（2 days）
Difference of Pulse Wave Velocity (baPW) among subjects with low/high CETP mass/activity and HDL-C level
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Pulse Wave Velocity (baPW) was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
participants will be followed for the duration of hospital stay（2 days）
Difference of IMT and Plaque Score of Carotid artery among subjects with low/high CETP mass/activity and HDL-C level
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of IMT and Plaque Score of Carotid artery was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
participants will be followed for the duration of hospital stay（2 days）
Difference of CETP activity between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of CETP activity was assessed between in those who do not satisfy any of these three conditions (normolipidemic subjects) and those who satisfy any of these three conditions (patients with dyslipidemia); LDL-C:100 mg/dl and above, HDL:80 mg/dl and above, TG:150 mg/dl and above.
participants will be followed for the duration of hospital stay（2 days）
Difference of Antioxidant activity between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Antioxidant activity was assessed between normolipidemic subjects and patients with dyslipidemia;HDL from subjects' serum samples will be added to LDL with 2,2'-azobis(2-amidinopropane) dihydrochloride (AAPH).
participants will be followed for the duration of hospital stay（2 days）
Difference of Monocyte chemoattractant protein-1 (MCP-1) concentration between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of MCP-1 concentration was assessed between normolipidemic subjects and patients with dyslipidemia
participants will be followed for the duration of hospital stay（2 days）
Difference of Cholesterol efflux between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Cholesterol efflux by HDL from macrophage was assessed between normolipidemic subjects and patients with dyslipidemia
participants will be followed for the duration of hospital stay（2 days）
Difference of Proteome analysis of lipoproteins between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Proteome analysis of lipoproteins (HDL, LDL, remnant binding protein) was assessed between normolipidemic subjects and patients with dyslipidemia
participants will be followed for the duration of hospital stay（2 days）

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference of Fasting blood glucose and HbA1c among subjects with low/high CETP mass/activity and HDL-C level
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Fasting blood glucose and HbA1c was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
participants will be followed for the duration of hospital stay（2 days）
Difference of waist circumference among subjects with low/high CETP mass/activity and HDL-C level
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of waist circumference was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
participants will be followed for the duration of hospital stay（2 days）
Difference of Smoking habits, alcohol taking habits and fitness habits among subjects with low/high CETP mass/activity and HDL-C level
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Smoking habits, alcohol taking habits and fitness habits was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
participants will be followed for the duration of hospital stay（2 days）
Difference of BMI among subjects with low/high CETP mass/activity and HDL-C level
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of BMI was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
participants will be followed for the duration of hospital stay（2 days）
Difference of Blood Pressure among subjects with low/high CETP mass/activity and HDL-C level
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Blood Pressure was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
participants will be followed for the duration of hospital stay（2 days）
Difference of 75g glucose tolerance test and calculated homeostasis model assessment of insulin resistance (HOMA-IR) among subjects with low/high CETP mass/activity and HDL-C level
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of 75g glucose tolerance test and calculated homeostasis model assessment of insulin resistance (HOMA-IR) was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
participants will be followed for the duration of hospital stay（2 days）
Difference of Total Cholesterol(TC) among subjects with low/high CETP mass/activity and HDL-C level
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Total Cholesterol(TC) was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
participants will be followed for the duration of hospital stay（2 days）
Difference of low density lipoprotein-cholesterol (LDL-C) among subjects with low/high CETP mass/activity and HDL-C level
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of low density lipoprotein-cholesterol (LDL-C) was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
participants will be followed for the duration of hospital stay（2 days）
Difference of triglyceride (TG) among subjects with low/high CETP mass/activity and HDL-C level
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of triglyceride (TG) was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
participants will be followed for the duration of hospital stay（2 days）
Difference of Serum adiponectin among subjects with low/high CETP mass/activity and HDL-C level
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference ofSerum adiponectin was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
participants will be followed for the duration of hospital stay（2 days）
Difference of Apolipoprotein (apo)B-48 concentrations among subjects with low/high CETP mass/activity and HDL-C level
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Apolipoprotein (apo)B-48 concentrations was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
participants will be followed for the duration of hospital stay（2 days）
Difference of Remnant lipoprotein (RemL-C) among subjects with low/high CETP mass/activity and HDL-C level
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Remnant lipoprotein (RemL-C) was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
participants will be followed for the duration of hospital stay（2 days）
Difference of Lipoprotein Profile between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Lipoprotein Profile analyzed by high performance liquid chromatography(HPLC) method was assessed between in those who do not satisfy any of these three conditions (normolipidemic subjects) and those who satisfy any of these three conditions (patients with dyslipidemia); LDL-C:100 mg/dl and above, HDL:80 mg/dl and above, TG:150 mg/dl and above.
participants will be followed for the duration of hospital stay（2 days）
Difference of apolipoprotein(apo)B-48 concentrations between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of apoB-48 concentrations was assessed between in normolipidemic subjects and in patients with dyslipidemia
participants will be followed for the duration of hospital stay（2 days）
Difference of Remnant lipoprotein (RemL-C) between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
Time Frame: participants will be followed for the duration of hospital stay（2 days）
The difference of RemL-C was assessed between in normolipidemic subjects and in patients with dyslipidemia
participants will be followed for the duration of hospital stay（2 days）

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Osaka University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Shizuya Yamashita, MD, PhD, FAHA, FJCC, Osaka University Graduate School of Medicine
  • Study Director: Etsuko Fushimi, MD, PhD, Hiraga General Hospital
  • Study Director: Hiroshi Itoh, MD, PhD, Akita University Graduate School of Medicine
  • Study Director: Norimichi Nakajima, MD, Nakajima Naika Clinic
  • Study Director: Yoshinobu Ikeda, MD, Ikeda Clinic
  • Study Director: Yuji Matsuzawa, MD, PhD, Sumitomo Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INFINITY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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