Gut Microbiome and Obesity

Study Overview
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Brief Summary
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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.

Official Title
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Gut Microbiome As Target of Intervention Against Obesity and Metabolic Syndrome

Conditions
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Obesity, Childhood, Metabolic Syndrome

Intervention / Treatment
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* Other: Obese with or without metabolic syndromesubjects


Participation Criteria
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Eligibility Criteria
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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, 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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese subjects<br>Subjects with obesity | Other: Obese with or without metabolic syndromesubjects<br>* Children with obesity and with or without metabolic syndrome<br>|
| Obese plus metabolic syndrome subjects<br>Subjects with obesity and metabolic syndrome | Other: Obese with or without metabolic syndromesubjects<br>* Children with obesity and with or without metabolic syndrome<br>|
| Healthy controls<br>Otherwise healthy subjects | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of metagenomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls | Evaluation of gut microbiota composition | at enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls | Evaluation of butyrate | at enrollment | 
| Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls | Evaluation of acetate | at enrollment | 
| Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls | Evaluation of propionate | at enrollment | 
| Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls | Evaluation of indole | at enrollment |