NCT04451148

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

June 25, 2020

Last Update Submit

July 1, 2020

Conditions

Obesity, ChildhoodMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Concentration of metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls

    at enrollment

  • 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 the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls

    at enrollment

  • Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls

    at enrollment

Study Arms (3)

Obese subjects

Subjects with obesity

Other: Obese with or without metabolic syndromesubjects

Obese plus metabolic syndrome subjects

Subjects with obesity and metabolic syndrome

Other: Obese with or without metabolic syndromesubjects

Healthy controls

Otherwise healthy subjects

Interventions

Obese with or without metabolic syndromesubjectsOTHER

Children with obesity and with or without metabolic syndrome

Obese plus metabolic syndrome subjectsObese subjects

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability 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)

You may qualify if:

  • Subjects aged between 10-16 years,
  • diagnosis of obesity or obesity complicated by metabolic syndrome
  • healthy controls

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Pediatric ObesityMetabolic Syndrome

Interventions

Adiposity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Body Fat DistributionBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisBody CompositionBiochemical PhenomenaChemical PhenomenaMetabolismPhysiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associate Professor

Study Record Dates

First Submitted

June 25, 2020

First Posted

June 30, 2020

Study Start

May 1, 2020

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

July 7, 2020

Record last verified: 2020-07

Locations

IT(1)