Gut Microbiome and Obesity

• Conditions: Obesity, Childhood; Metabolic Syndrome
• Interventions: Other: Obese with or without metabolic syndromesubjects

• Registration Number: NCT04451148
• Lead Sponsor: Federico II University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-07
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese subjects	Obese with or without metabolic syndromesubjects	Subjects with obesity
Obese plus metabolic syndrome subjects	Obese with or without metabolic syndromesubjects	Subjects with obesity and metabolic syndrome

Primary Outcome Measures

Name	Time	Method
Concentration of metagenomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls	at enrollment	Evaluation of gut microbiota composition

Secondary Outcome Measures

Name	Time	Method
Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls	at enrollment	Evaluation of indole
Concentration of metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls	at enrollment	Evaluation of butyrate

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 Naples, Italy