NCT03014856

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

Status
completed

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, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

1.6 years

First QC Date

December 13, 2016

Last Update Submit

January 5, 2017

Conditions

Keywords

Metabolic syndromeMetabolomicsNMR spectroscopy

Outcome Measures

Primary Outcomes (1)

  • metabolic phenotype of childhood obesity

    Significant metabolic changes in blood plasma of obese children and adolescents and normal-weight control subjects

    day 1

Secondary Outcomes (1)

  • metabolic phenotype of metabolically healthy and unhealthy obese children and adolescents

    day 1

Study Arms (2)

OB-NMR

overweight and obese children and adolescents

Other: Blood sampling

NMR-C

normal-weight children and adolescents

Other: Blood sampling

Interventions

Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy

NMR-COB-NMR

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

65 overweight and obese (OB) children and 37 normal-weight (NW) controls aged 8 to 18 years

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Beckonert O, Keun HC, Ebbels TM, Bundy J, Holmes E, Lindon JC, Nicholson JK. Metabolic profiling, metabolomic and metabonomic procedures for NMR spectroscopy of urine, plasma, serum and tissue extracts. Nat Protoc. 2007;2(11):2692-703. doi: 10.1038/nprot.2007.376.

    PMID: 18007604BACKGROUND
  • Prince RL, Kuk JL, Ambler KA, Dhaliwal J, Ball GD. Predictors of metabolically healthy obesity in children. Diabetes Care. 2014 May;37(5):1462-8. doi: 10.2337/dc13-1697. Epub 2014 Feb 26.

    PMID: 24574347BACKGROUND
  • Butte NF, Liu Y, Zakeri IF, Mohney RP, Mehta N, Voruganti VS, Goring H, Cole SA, Comuzzie AG. Global metabolomic profiling targeting childhood obesity in the Hispanic population. Am J Clin Nutr. 2015 Aug;102(2):256-67. doi: 10.3945/ajcn.115.111872. Epub 2015 Jun 17.

    PMID: 26085512BACKGROUND
  • Perng W, Gillman MW, Fleisch AF, Michalek RD, Watkins SM, Isganaitis E, Patti ME, Oken E. Metabolomic profiles and childhood obesity. Obesity (Silver Spring). 2014 Dec;22(12):2570-8. doi: 10.1002/oby.20901. Epub 2014 Sep 24.

    PMID: 25251340BACKGROUND
  • Mihalik SJ, Michaliszyn SF, de las Heras J, Bacha F, Lee S, Chace DH, DeJesus VR, Vockley J, Arslanian SA. Metabolomic profiling of fatty acid and amino acid metabolism in youth with obesity and type 2 diabetes: evidence for enhanced mitochondrial oxidation. Diabetes Care. 2012 Mar;35(3):605-11. doi: 10.2337/DC11-1577. Epub 2012 Jan 20.

    PMID: 22266733BACKGROUND
  • Wahl S, Yu Z, Kleber M, Singmann P, Holzapfel C, He Y, Mittelstrass K, Polonikov A, Prehn C, Romisch-Margl W, Adamski J, Suhre K, Grallert H, Illig T, Wang-Sattler R, Reinehr T. Childhood obesity is associated with changes in the serum metabolite profile. Obes Facts. 2012;5(5):660-70. doi: 10.1159/000343204. Epub 2012 Oct 4.

    PMID: 23108202BACKGROUND
  • Bervoets L, Massa G, Guedens W, Reekmans G, Noben JP, Adriaensens P. Identification of metabolic phenotypes in childhood obesity by 1H NMR metabolomics of blood plasma. Future Sci OA. 2018 May 23;4(6):FSO310. doi: 10.4155/fsoa-2017-0146. eCollection 2018 Jul.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma for proton-NMR spectroscopy

MeSH Terms

Conditions

Pediatric ObesityMetabolic Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Peter Adriaensens, PhD

    Institute of Material Research, Hasselt University

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor (hoogleraar)

Study Record Dates

First Submitted

December 13, 2016

First Posted

January 9, 2017

Study Start

May 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

January 9, 2017

Record last verified: 2017-01