Relationship Between CETP Deficiency and Atherosclerosis in Patients With Hyperalphalipoproteinemia

Hyper-LDL-cholesterolemia Clinical Trial

— INFINITY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01916512
• Other study ID #: INFINITY
• Status: Recruiting
• Phase: N/A
• First received: July 22, 2013
• Last updated: April 14, 2015
• Start date: February 2012

Study information

• Verified date: August 2013
• Source: Osaka University
• Contact: Shizuya Yamashita, MD, PhD, FAHA, FJCC
• Phone: +81-6-6879-3633
• Email: shizu[@]cardiology.med.osaka-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Atherosclerosis
• CETP Deficiency
• High Level of Remnant Cholesterol
• Hyper-LDL-cholesterolemia
• Hyperalphalipoproteinemia
• Hypercholesterolemia
• Lipid Metabolism, Inborn Errors
• Low CETP Activity

Locations

Country	Name	City	State
Japan	Osaka University Graduate School of Medicine	Suita	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Osaka University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of Ischemic changes of ECG among subjects with low/high CETP mass/activity and HDL-C level	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)	No
Primary	Difference of Calc Score of Aorta by Chest X-ray among subjects with low/high CETP mass/activity and HDL-C level	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)	No
Primary	Difference of Ankle Brachial Index (ABI) among subjects with low/high CETP mass/activity and HDL-C level	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)	No
Primary	Difference of Pulse Wave Velocity (baPW) among subjects with low/high CETP mass/activity and HDL-C level	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)	No
Primary	Difference of IMT and Plaque Score of Carotid artery among subjects with low/high CETP mass/activity and HDL-C level	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)	No
Primary	Difference of CETP activity between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)	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)	No
Primary	Difference of Antioxidant activity between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)	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)	No
Primary	Difference of Monocyte chemoattractant protein-1 (MCP-1) concentration between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)	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)	No
Primary	Difference of Cholesterol efflux between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)	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)	No
Primary	Difference of Proteome analysis of lipoproteins between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)	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)	No
Secondary	Difference of Fasting blood glucose and HbA1c among subjects with low/high CETP mass/activity and HDL-C level	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)	No
Secondary	Difference of waist circumference among subjects with low/high CETP mass/activity and HDL-C level	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)	No
Secondary	Difference of Smoking habits, alcohol taking habits and fitness habits among subjects with low/high CETP mass/activity and HDL-C level	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)	No
Secondary	Difference of BMI among subjects with low/high CETP mass/activity and HDL-C level	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)	No
Secondary	Difference of Blood Pressure among subjects with low/high CETP mass/activity and HDL-C level	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)	No
Secondary	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	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)	No
Secondary	Difference of Total Cholesterol(TC) among subjects with low/high CETP mass/activity and HDL-C level	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)	No
Secondary	Difference of low density lipoprotein-cholesterol (LDL-C) among subjects with low/high CETP mass/activity and HDL-C level	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)	No
Secondary	Difference of triglyceride (TG) among subjects with low/high CETP mass/activity and HDL-C level	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)	No
Secondary	Difference of Serum adiponectin among subjects with low/high CETP mass/activity and HDL-C level	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)	No
Secondary	Difference of Apolipoprotein (apo)B-48 concentrations among subjects with low/high CETP mass/activity and HDL-C level	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)	No
Secondary	Difference of Remnant lipoprotein (RemL-C) among subjects with low/high CETP mass/activity and HDL-C level	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)	No
Secondary	Difference of Lipoprotein Profile between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)	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)	No
Secondary	Difference of apolipoprotein(apo)B-48 concentrations between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)	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)	No
Secondary	Difference of Remnant lipoprotein (RemL-C) between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)	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)	No