Gut Microbiome As Target of Intervention Against Obesity and Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Concentration of metagenomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
研究概览
简要总结
Pediatric obesity is a risk factor for the onset of obesity in adulthood and is a risk factor for various chronic non-communicable diseases. Metabolic syndrome (MS) is the name for a group of risk factors that increase cardiovascular risk and other health problems characterized by the presence of abdominal obesity, dyslipidemia, hyperglycaemia and high blood pressure. Numerous preclinical and clinical data suggest a potential role of the intestinal microbiota in these diseaes. Unfortunately, comparative studies of the gut microbiota are still scarce in pediatric subjects suffering from obesity than obesity complicated by MS. The aim is to study the metagenomics and metabolomics characteristics of the intestinal microbiota in obese children/adolescents with or without MS, that could provide useful data for innovative intervention strategies for these conditions.
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
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 10-16 years,
- •diagnosis of obesity or obesity complicated by metabolic syndrome
- •healthy controls
排除标准
- •Age at enrollment < 10 or >16 years,
- •concomitant presence of chronic diseases,
- •neoplasms,
- •immunodeficiencies,
- •chronic infections,
- •autoimmune diseases,
- •chronic inflammatory bowel diseases,
- •celiac disease, -genetic-metabolic diseases, -
- •cystic fibrosis
- •chronic lung diseases,
- •malformations of the cardiovascular/respiratory/gastrointestinal system,
- •neuropsychiatric disorders
- •neurological pathologies,
- •assumption of antibiotics and/or pre/pro/synbiotics
- •onset of diarrhea or acute gastrointestinal disease during the 12 weeks prior to enrollment.
结局指标
主要结局
Concentration of metagenomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
时间窗: at enrollment
Evaluation of gut microbiota composition
次要结局
- Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls(at enrollment)
- Concentration of metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls(at enrollment)
研究者
Roberto Berni Canani
MD, Associate Professor
Federico II University