Gut Microbiome As Target of Intervention Against Obesity and Metabolic Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity, Childhood
- Sponsor
- Federico II University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Concentration of metagenomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Roberto Berni Canani
MD, Associate Professor
Federico II University
Eligibility Criteria
Inclusion Criteria
- •Subjects aged between 10-16 years,
- •diagnosis of obesity or obesity complicated by metabolic syndrome
- •healthy controls
Exclusion Criteria
- •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,
Outcomes
Primary Outcomes
Concentration of metagenomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
Time Frame: at enrollment
Evaluation of gut microbiota composition
Secondary Outcomes
- 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)