Clinical trial NCT01916512: Relationship Between CETP Deficiency and Atherosclerosis in Patients With Hyperalphalipoproteinemia
Official title: Investigation of Relationship Between Cholesteryl Ester Transfer Protein Deficiency and Carotid/Coronary Atherosclerosis in Patients With Hyperalphalipoproteinemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low CETP Activity
CETP Deficiency
Hyperalphalipoproteinemia
Hyper-LDL-cholesterolemia
High Level of Remnant Cholesterol
Keywords: CETP, HDL, LDL, apoB-100, apoB-48, remnants
Lead sponsor: Osaka University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-08-05
Enrollment: 1500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Difference of Ischemic changes of ECG among subjects with low/high CETP mass/activity and HDL-C level
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of Calc Score of Aorta by Chest X-ray among subjects with low/high CETP mass/activity and HDL-C level
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of Ankle Brachial Index (ABI) among subjects with low/high CETP mass/activity and HDL-C level
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of Pulse Wave Velocity (baPW) among subjects with low/high CETP mass/activity and HDL-C level
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of IMT and Plaque Score of Carotid artery among subjects with low/high CETP mass/activity and HDL-C level
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of CETP activity between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of Antioxidant activity between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of Monocyte chemoattractant protein-1 (MCP-1) concentration between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of Cholesterol efflux between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of Proteome analysis of lipoproteins between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
timeFrame: participants will be followed for the duration of hospital stay（2 days）
Secondary outcomes:
measure: Difference of Fasting blood glucose and HbA1c among subjects with low/high CETP mass/activity and HDL-C level
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of waist circumference among subjects with low/high CETP mass/activity and HDL-C level
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of Smoking habits, alcohol taking habits and fitness habits among subjects with low/high CETP mass/activity and HDL-C level
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of BMI among subjects with low/high CETP mass/activity and HDL-C level
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of Blood Pressure among subjects with low/high CETP mass/activity and HDL-C level
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: 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
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of Total Cholesterol(TC) among subjects with low/high CETP mass/activity and HDL-C level
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of low density lipoprotein-cholesterol (LDL-C) among subjects with low/high CETP mass/activity and HDL-C level
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of triglyceride (TG) among subjects with low/high CETP mass/activity and HDL-C level
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of Serum adiponectin among subjects with low/high CETP mass/activity and HDL-C level
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of Apolipoprotein (apo)B-48 concentrations among subjects with low/high CETP mass/activity and HDL-C level
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of Remnant lipoprotein (RemL-C) among subjects with low/high CETP mass/activity and HDL-C level
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of Lipoprotein Profile between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of apolipoprotein(apo)B-48 concentrations between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
timeFrame: participants will be followed for the duration of hospital stay（2 days）
measure: Difference of Remnant lipoprotein (RemL-C) between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
timeFrame: participants will be followed for the duration of hospital stay（2 days）
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Osaka University Graduate School of Medicine
state: Osaka
Study officials:
affiliation: Osaka University Graduate School of Medicine
name: Shizuya Yamashita, MD, PhD, FAHA, FJCC
role: STUDY_CHAIR
affiliation: Hiraga General Hospital
name: Etsuko Fushimi, MD, PhD
role: STUDY_DIRECTOR
affiliation: Akita University Graduate School of Medicine
name: Hiroshi Itoh, MD, PhD
role: STUDY_DIRECTOR
affiliation: Nakajima Naika Clinic
name: Norimichi Nakajima, MD
role: STUDY_DIRECTOR
affiliation: Ikeda Clinic
name: Yoshinobu Ikeda, MD
role: STUDY_DIRECTOR
affiliation: Sumitomo Hospital
name: Yuji Matsuzawa, MD, PhD
role: STUDY_DIRECTOR
References: