Clinical Trial: Relationship Between CETP Deficiency and Atherosclerosis in Patients With Hyperalphalipoproteinemia

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Osaka University

Current Primary Outcome:

  • 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
  • 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
  • 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
  • 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 W

    Original Primary Outcome:

    • 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
    • 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
    • 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
    • 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 W

      Current Secondary Outcome:

      • 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
      • 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
      • 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
      • 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
      • 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
      • 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
      • 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
      • 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
      • 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
      • 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
      • 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/activi

        Original Secondary Outcome:

        • 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
        • 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
        • 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
        • 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
        • 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
        • 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
        • 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
        • 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
        • 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
        • 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
        • 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/activi

          Information By: Osaka University

          Dates:
          Date Received: July 22, 2013
          Date Started: February 2012
          Date Completion:
          Last Updated: April 14, 2015
          Last Verified: August 2013