Lipoprotein Metabolism in Normal Volunteers and Hyperlipoproteinemic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 759
- 试验地点
- 1
- 主要终点
- No outcome. This is a disease discover protocol.
研究概览
简要总结
Researchers plan to study the fat-rich particles, called lipoproteins, which circulate in the blood. This study is designed to improve understanding of normal, as well as abnormal, lipoprotein metabolism and the role it plays in the development of hardening of the arteries (atherosclerosis).
Patients participating in this study will receive injections of lipoproteins or apolipoproteins (the protein component of lipoproteins) that have been isolated and purified. These lipoproteins will be labeled with small amounts of radioactive material and sterilized before they are injected into the patient.
Patients participating in the study will be required to have blood samples taken, and provide urine samples throughout the course of the study. In addition, patient will be required to follow a specially formulated diet. Patients will be weighed throughout the course of the study.
详细描述
We propose to investigate human in vivo lipoprotein metabolism using radiolabeled apolipoproteins on plasma lipoproteins. Paired kinetic studies using dual-labeled iodinated lipoproteins and apolipoproteins are performed in healthy volunteer controls with normal lipids and subjects with dyslipidemia under controlled metabolic conditions. Studies are designed to formulate metabolic pathways in patients with undefined genetic disorders of lipid metabolism as well as in healthy volunteers to provide original insights into normal and pathologic metabolic pathways. All kinetic data is computer analyzed to provide quantitative data and facilitate direct comparison of multiple studies.
研究设计
- 研究类型
- 观察性
- 观察模型
- 仅病例
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Subjects with new and undefined dyslipidemia-particularly familial disorders with extreme phenotypes.
- Healthy normal volunteers - (18 years old or older) controls to investigate the formation of HDL for prebeta HDL.
- Euthyroid.
排除标准
- Healthy control volunteers are initially screened for secondary causes of hyperlipidemia and are excluded if they have any clinically significant laboratory abnormality (i.e., liver disease, disease, kidney disease, endocrine disease,), chronic medical problems (i.e., hypertension, migraines, inflammatory bowel, hepatitis, HIV) or require any chronic medications (i.e., acne, asthma).
- The healthy control volunteers weight must fall within the current guidelines for ideal body weight.
- Pregnant women.
- Unwilling to follow metabolic diet.
- Allergic to iodine.
- Unable to sign consent form.
研究组 & 干预措施
Patients
Subjects with new and undefined dyslipidemia
结局指标
主要结局
No outcome. This is a disease discover protocol.
时间窗: 5 years
Dyslipidemia
次要结局
未报告次要终点
研究者
研究点 (1)
标识符
- NCT 编号
- NCT00001154
- 其他研究编号
- 760051, 76-H-0051
日期
- 首次提交
- (26年前)
- 首次发布
- (26年前)
- 最近核实
- (5个月前)
- 最近更新
- (22天前)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否