NCT01333436已完成不适用
A Multicenter, Cross-sectional Study to Evaluate Plasma ApoB-48 Concentration Among Korean Diabetic Patients (With Normal to Moderately High LDL-C Levels)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48)
研究概览
简要总结
This study will evaluate whether fasting/postprandial serum ApoB-48 levels are increased in diabetic participants compared to nondiabetic participants with the same range of serum LDL-C levels, and whether ApoB-48 levels can be used, along with LDL-C levels, to identify potential cardiovascular disease risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant has an LDL-C ranging from ≥100 mg/dL to <160 mg/dL.
- •Patient has a triglyceride (TG) level of ≤500 mg/dL.
排除标准
- •Participant treated with a lipid-lowering agent in the 6 weeks prior to Visit 1 (screening period).
- •Participant has active liver disease or persistent unexplained serum transaminase elevations (≥2 x the upper limit of normal [ULN])
- •Participant has increased creatine kinase (CK) (≥2 x ULN).
- •Participant has a history of type 1 diabetes mellitus, ketoacidosis, or gestational diabetes mellitus.
- •Participant has a history of alcohol and/or drug abuse.
研究组 & 干预措施
Diabetic participants
Experimental
Diabetic participants with normal to moderately high LDL-C
干预措施: Test Meal (Other)
Nondiabetic participants
Experimental
Non-diabetic participants with normal to moderately high LDL-C
干预措施: Test Meal (Other)
结局指标
主要结局
Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48)
时间窗: up to 6 hours after Test Meal
ApoB-48 levels were measured at 1, 2, 3, 4, and 6 hours after the administration of the test meal.
次要结局
- Fasting ApoB-48 Levels(Baseline (Hour 0))
- Postprandial Mean ApoB-48 Peak Levels(up to 6 hours after Test Meal)
研究者
研究点 (1)
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