Gut Microbiome and Obesity (MATOMS)

Gut Microbiome As Target of Intervention Against Obesity and Metabolic Syndrome

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.

Study Overview

• Status: Unknown
• Conditions: Metabolic Syndrome; Obesity, Childhood
• Intervention / Treatment: Other: Obese with or without metabolic syndromesubjects

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • University of Naples Federico II
    • Contact: Roberto Berni Canani, MD, PhD; Phone Number: +390817462680; Email: berni@unina.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children/adolescents of both sexes, aged between 10-16 years, with obesity, obesity complicated by metabolic syndrome and healthy controls observed at Pediatrics Section of Department of Translational Medical Sciences (University of Naples Federico II)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obese subjects; Subjects with obesity	Other: Obese with or without metabolic syndromesubjects; Children with obesity and with or without metabolic syndrome
Obese plus metabolic syndrome subjects; Subjects with obesity and metabolic syndrome	Other: Obese with or without metabolic syndromesubjects; Children with obesity and with or without metabolic syndrome
Healthy controls; Otherwise healthy subjects

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2020
• Primary Completion (ANTICIPATED): May 1, 2022
• Study Completion (ANTICIPATED): May 1, 2022

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (ACTUAL): June 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Syndrome; Obesity; Metabolic Syndrome; Pediatric Obesity
• Other Study ID Numbers: 103/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No