Characterization of Serum Proteome in Young Obese Subjects With Different Degrees of Liver Steatosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Identification of serum markers (proteomic analysis) for the characterization of steatosis in young subjects with essential obesity
研究概览
简要总结
With the project proposal we aim to identify serum markers for the characterization of steatosis in subjects affected by essential obesity at a young age. In this case the markers could be useful not only for the development of new diagnostic scores, or for combining them with diagnostic imaging technologies, but also for understanding the metabolic alterations according to the patient's gender, extremely important data in this disease to which only recently has biomedical research started.
详细描述
Experimental design The study includes a discovery phase in which a serum proteomic analysis of the subjects included in the study will be performed. This phase will make it possible to identify a small number of possible candidate markers, which will be validated in a subsequent phase with a greater number of subjects.
Patients:
In the discovery phase, 60 pubescent subjects (30 males and 30 females) will be taken into consideration. The subjects will be divided into two groups:
- control group including subjects with absence of steatosis, verified by ultrasound method according to standardized criteria [10,11], and with APRI score < 0.3;
- study group with subjects with the proven presence of steatosis using ultrasound techniques, and with APRI score > 0.50.
For each patient, the following variables will be considered in baseline conditions, i.e. at the time of sample collection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •obesity (BMI SDS > 2)
- •age range: 13-18
排除标准
- •age < 13 years and > 18 years
结局指标
主要结局
Identification of serum markers (proteomic analysis) for the characterization of steatosis in young subjects with essential obesity
时间窗: Baseline
Identification of serum markers (proteomic analysis)for the characterization of steatosis in young subjects with essential obesity
次要结局
- Relationships between proteoma and body composition (evaluated throughout bioimpedentiometry)(Baseline)