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Metabolic Phenotypes in Childhood Obesity

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ClinicalTrials.gov Identifier: NCT03014856
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Collaborator:
Jessa Hospital
Information provided by (Responsible Party):
Peter Adriaensens, Hasselt University

Brief Summary:
This study provides a sound basis towards a better understanding of the biochemical mechanisms behind childhood obesity and its metabolic phenotypes, which will be of great importance towards the development of more personalized prevention and treatment in future.

Condition or disease Intervention/treatment
Obesity, Pediatric Other: Blood sampling

Detailed Description:

The aim of this study was to identify the plasma metabolic profile associated with childhood obesity and its phenotypes..

This cross-sectional study was set-up to examine the metabolic profile in fasting plasma samples from 65 overweight and obese (OB) children and 37 normal-weight (NW) controls aged 8 to 18 years. The obtained plasma 1H-NMR spectra were rationally divided into 110 integration regions, representing the metabolic phenotype. These integration regions reflect the relative metabolite concentrations and were used as statistical variables to construct a classification model in discriminating between OB and NW children and adolescents. In addition, two metabolic phenotypes were defined within the OB group, i.e. the metabolically "healthy" obese (MHO) and metabolically unhealthy obese (MUO) phenotype which are both classified as obese but with respectively, none (MHO) or at least two components (MUO) of the metabolic syndrome.

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Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Identification of Metabolic Phenotypes in Childhood Obesity by 1H-NMR Metabolomics of Blood Plasma
Study Start Date : May 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2014

Group/Cohort Intervention/treatment
OB-NMR
overweight and obese children and adolescents
Other: Blood sampling
Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy

NMR-C
normal-weight children and adolescents
Other: Blood sampling
Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy




Primary Outcome Measures :
  1. metabolic phenotype of childhood obesity [ Time Frame: day 1 ]
    Significant metabolic changes in blood plasma of obese children and adolescents and normal-weight control subjects


Secondary Outcome Measures :
  1. metabolic phenotype of metabolically healthy and unhealthy obese children and adolescents [ Time Frame: day 1 ]
    Significant metabolic changes in blood plasma of metabolically healthy obese and metabolically unhealthy obese children and adolescents


Biospecimen Retention:   Samples Without DNA
Blood plasma for proton-NMR spectroscopy


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
65 overweight and obese (OB) children and 37 normal-weight (NW) controls aged 8 to 18 years
Criteria

Inclusion Criteria:

  • aged 8 to 18
  • normal-weight, overweight or obese according to the International Obesity Task Force (IOTF) Body Mass Index (BMI) criteria
  • fasted for at least 8 hours

Exclusion Criteria:

  • Subjects taking any medication or having serious chronic or acute illness within two weeks preceding the clinical examination,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014856


Sponsors and Collaborators
Hasselt University
Jessa Hospital
Investigators
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Principal Investigator: Peter Adriaensens, PhD Institute of Material Research, Hasselt University
Study Chair: Liene Bervoets, PhD Hasselt University
Study Chair: Guy Massa, PhD, MD Jessa Ziekenhuis Hasselt
Study Chair: Wanda Guedens, PhD Institute of Material Research, Hasselt University
Study Chair: Gunter Reekmans, Ing Institute of Material Research, Hasselt University
Study Chair: Jean-Paul Noben, PhD BIOMED, Hasselt University
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peter Adriaensens, Professor (hoogleraar), Hasselt University
ClinicalTrials.gov Identifier: NCT03014856    
Other Study ID Numbers: LCRP-OBNMR
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Keywords provided by Peter Adriaensens, Hasselt University:
Metabolic syndrome
Metabolomics
NMR spectroscopy
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight