Relationship Between CETP Deficiency and Atherosclerosis in Patients With Hyperalphalipoproteinemia

NCT01916512 | Unknown

• 1 other identifier: INFINITY
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Low CETP Activity; CETP Deficiency; Hyperalphalipoproteinemia; Hyper-LDL-cholesterolemia; High Level of Remnant Cholesterol

Keywords

CETP, HDL, LDL, apoB-100, apoB-48, remnants

Outcome Measures

Primary Outcomes (10)

• 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）

• 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）

• 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）

• 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）

• 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）

• 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）

• 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）

• 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）

• 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）

• 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）

Secondary Outcomes (15)

• 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 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 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 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）

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Osaka University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Osaka University Graduate School of Medicine

Suita, Osaka, 565-0879, Japan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma

MeSH Terms

Conditions

Cholesteryl Ester Transfer Protein Deficiency

Study Officials

• Shizuya Yamashita, MD, PhD, FAHA, FJCC

  Osaka University Graduate School of Medicine

  STUDY CHAIR

• 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 DIRECTOR

Central Study Contacts

Shizuya Yamashita, MD, PhD, FAHA, FJCC

CONTACT

+81-6-6879-3633; shizu@cardiology.med.osaka-u.ac.jp

Daisaku Masuda, MD, PhD

CONTACT

+81-6-6879-3633; masuda@cardiology.med.osaka-u.ac.jp

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: August 5, 2013
• Study Start: February 1, 2012
• Primary Completion: March 1, 2016
• Last Updated: April 15, 2015

Record last verified: 2013-08

Locations

JP (1)