- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03014856
Metabolic Phenotypes in Childhood Obesity
Identification of Metabolic Phenotypes in Childhood Obesity by 1H-NMR Metabolomics of Blood Plasma
Study Overview
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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,
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
OB-NMR
overweight and obese children and adolescents
|
Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy
|
NMR-C
normal-weight children and adolescents
|
Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
day 1
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Adriaensens, PhD, Institute of Material Research, Hasselt University
- Study Chair: Guy Massa, PhD, MD, Jessa Ziekenhuis Hasselt
- Study Chair: Liene Bervoets, PhD, Hasselt University
- 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 and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCRP-OBNMR
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