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Clinical Trials/NCT01916512
NCT01916512
Unknown
Not Applicable

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

Osaka University1 site in 1 country1,500 target enrollmentFebruary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low CETP Activity
Sponsor
Osaka University
Enrollment
1500
Locations
1
Primary Endpoint
Difference of Ischemic changes of ECG among subjects with low/high CETP mass/activity and HDL-C level
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
March 2016
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 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.

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

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

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

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).

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

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

Secondary Outcomes

  • Difference of waist circumference among subjects with low/high CETP mass/activity and 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(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(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)(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(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(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(participants will be followed for the duration of hospital stay(2 days))
  • Difference of Fasting blood glucose and HbA1c among subjects with low/high CETP mass/activity and 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(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(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(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(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(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)(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)(participants will be followed for the duration of hospital stay(2 days))

Study Sites (1)

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