Measurements of Lipoproteins, Apolipoproteins and Lipids - Determination of Pre-analytical Variables for Analysis of Blood Collected From Fasting and Post-prandial Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in Total Cholesterol
研究概览
简要总结
Participants in this study will have one visit to the Emory University Hospital Clinical Research Unit. Participants will consume, over 5 minutes, a single standardized fat challenge (100 grams), using a commercially available liquid high-energy long chain triglyceride fat emulsion (Calogen), which provides 50 grams of long chain triglycerides per 100 mL. Participants will have 20 mL blood withdrawn at six successive time points over an 8-hour period, where the first time point after fasting (baseline) is followed by 5 time-points after fat consumption. Blood will be analyzed for a wide panel of blood lipids.
详细描述
Cardiovascular disease (CVD) is the leading killer of Americans, accounting more than 800,000 deaths each year. A vital step in reducing the number of heart disease-related deaths in the U.S. is to identify those at probable risk. The Clinical Chemistry Branch (CCB) in the Division of Laboratory Sciences (DLS) at the Centers for Disease Control and Prevention (CDC) has developed advanced analytical methods for assessing the risk for lipid metabolism related diseases, including CVD. CCB of the CDC has developed a comprehensive analytical method to measure levels of protein and lipid constituents of lipoprotein size/density classes (e.g. high-density lipoprotein (HDL), low-density lipoprotein (LDL) and very low-density lipoprotein (VLDL) in blood. CCB plans to eventually apply this method in future investigations of cohorts with different CVD states. The measurement of this wide array of CVD-linked biomarkers has the potential to improve the assessment of CVD risk over current clinical methods based on lipoprotein classes.
However, limited information is available about how the advanced tests developed by CCB are affected by blood collection conditions, such as fasting/non-fasting state of the subjects. The purpose of this study is to determine the relative significance of these pre-analytical variables and determine optimal conditions for future cohort studies.
This study will recruit up to 32 healthy individuals, with and without obesity, to participate. The study involves one visit to the Emory University Hospital Clinical Research Unit where participants will consume, over 5 minutes, a single standardized fat challenge (100 grams), using a commercially available liquid high-energy long chain triglyceride fat emulsion (Calogen; http://www.nutricia.ie/calogen#), which provides 50 grams of long chain triglycerides per 100 mL. Participants will have 20 mL blood withdrawn at six successive time points over an 8-hour period, where the first time point after fasting is followed by 5 time-points after fat (Calogen) consumption. Blood will be analyzed at the CCB for a wide panel of blood lipids and potential biomarkers for CVD.
Specific expected outcomes of the study include the following: 1) Determination of typical intra-individual differences between fasting and post-prandial states; and 2) Changes in the levels of the various analytes after fat consumption will be indicative of inter-individual differences in the rate of triglyceride depletion, and the rate of accumulation/depletion of HDL or LDL of different particle size range and composition. The results will allow the assessment of significant differences in lipid metabolism between individuals with a normal BMI (20 to 25 kg/m^2) versus those with a BMI in the obese range (30-35 kg/m^2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •functionally ambulatory
- •BMI between >20 to 40 kg/m^2
- •available for an 8 hour visit to the Emory University Hospital Clinical Research Center
排除标准
- •has taken any diabetic or lipid lowering prescription medications within the past 12 months
- •history of chronic diseases
- •hospitalized within the last year
- •currently pregnant
- •current active malignant neoplasm or history of malignancy (other than localized basal cell cancer of the skin) during the previous 5 years
- •current chronic autoimmune or pro-inflammatory disease
- •history of tuberculosis, HIV, or other chronic infection
- •previous diagnosis of type 1 or type 2 diabetes with active treatment with insulin or other glucose lowering medication
- •advanced (>= stage 3) renal disease
- •recreational or prescription drug or alcohol abuse
- •any history of gastrointestinal diseases, including malabsorption
- •any history of intolerance to dietary fat
- •inability to provide informed consent
结局指标
主要结局
Change in Total Cholesterol
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Total cholesterol profiles for each time-point will be compared between participants with normal BMI and participants with obese range BMI. Elevated total cholesterol has been thought to contribute to atherosclerotic events, however, research has also observed coronary events occurring in individuals with total cholesterol levels in the acceptable range.
Change in Phospholipid Transfer Protein
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Phospholipid transfer protein concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Serum Amyloid A1
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Serum amyloid A1 concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in low-density lipoprotein (LDL) Size
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
LDL concentration size profiles for each time-point will be compared between participants with normal BMI and participants with obese range BMI. LDL is considered to be atherogenic because it is likely to be trapped inside the intima of blood vessels and arteries and initiate inflammatory response, foam-cell formation, and smooth muscle cell proliferation, leading to development necrotic cores, lesions, plaques and their eventual rupture. Elevated LDL has been thought to contribute to atherosclerotic events, however, research has also observed coronary events occurring in individuals with LDL levels in the acceptable range.
Change in Free Cholesterol
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Free cholesterol concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI. Free cholesterol is unesterified cholesterol that is circulating in the blood stream.
Change in Phosphatidylethanolamine
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Phosphatidylethanolamine concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Lysophosphatidylcholine
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Lysophosphatidylcholine concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Sphingomyelin
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Sphingomyelin concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Apolipoprotein AII
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Apolipoprotein AII concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Apolipoprotein AIV
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Apolipoprotein AIV concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Apolipoprotein B
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Apolipoprotein B concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Serum Paraoxonase/arylesterase 1
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Serum paraoxonase/arylesterase 1 concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in high-density lipoprotein (HDL) Size
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
HDL concentration size profiles for each time-point will be compared between participants with normal BMI and participants with obese range BMI. HDL is considered to be anti-atherogenic because of its ability deplete excess cholesterol accumulating necrotic cores and repair arterial lesions.
Change in Triglycerides
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Triglyceride concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI. Triglycerides peak in serum 2 to 4 hours after a meal and return to a pre-meal state in 6 to 8 hours.
Change in Cholesterol Ester Transfer Protein
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Cholesterol ester transfer protein concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Cholesterol Ester
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Cholesterol ester concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI. Lipoproteins contain cholesterol ester, and cholesterol ester is associated with atherosclerosis.
Change in Phosphatidylinositol
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Phosphatidylinositol concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Phosphatidylcholine
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Phosphatidylcholine concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Apolipoprotein AI
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Apolipoprotein AI concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Apolipoprotein CII
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Apolipoprotein CII concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Apolipoprotein CIII
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Apolipoprotein CIII concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Lecithin-Cholesterol Acyltransferase
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Lecithin-cholesterol acyltransferase concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Lipoprotein (a)
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Lipoprotein (a) concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Apolipoprotein CI
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Apolipoprotein CI concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Apolipoprotein E
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Apolipoprotein E concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Serum Amyloid A4
时间窗: Hours 0, 0.5, 1, 2, 4, and 6
Serum amyloid A4 concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
次要结局
未报告次要终点
研究者
Thomas R. Ziegler
Professor
Emory University