Immunization Against oxLDL in Patients With Lysosomal Lipid Diseases and Associated Metabolic Disorders
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The level of inflammation
研究概览
简要总结
To test whether active pneumococci immunization can alleviate inflammation and improve cholesterol metabolism in lysosomal lipid storage diseases and associated metabolic disorders.
详细描述
Growing evidence describes the central role of oxidized low density lipoproteins (oxLDL) in diseases related to lipid metabolism. Moreover, oxLDL has been shown to be involved in pathological processes such as an inappropriate inflammatory response, disturbance of cholesterol metabolism and dysfunction of the lysosomal apparatus. Relevantly, it has been shown that immunizing mice with Streptococcus pneumoniae results in higher serum titers of anti-oxLDL IgM antibodies due to molecular mimicry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of following diseases (characterized by lysosomal lipid storage or associated metabolic pathology)
- •Familial hypercholesterolemia,
- •Partial lipodystrophy (PPARg mutations and laminin A/C mutations)
- •Intention to be treated and participate to the treatment - Written informed consent
排除标准
- •Medical conditions that may interfere with the study procedures: cancer Hodgkin lymphoma (all related to immune cells); autoimmune diseases; immune deficiency; splenectomy syndrome
- •Alcohol abuse (quantitative limit >20g/day for men and >10g for women)
- •Illiteracy
- •Patients younger than 10 years.
- •Any condition which in the opinion of the (co-) investigator might interfere with the evaluation of the study objectives.
结局指标
主要结局
The level of inflammation
时间窗: 4 weeks
次要结局
- Levels of lysosomal enzymes(4 weeks)
- the level of cholesterol metabolism(4 weeks)
研究者
Annick Vanclooster
Nurse
Universitaire Ziekenhuizen KU Leuven