Metabolic Phenotypes in Childhood Obesity

Obesity, Pediatric Clinical Trial

Official title:

Identification of Metabolic Phenotypes in Childhood Obesity by 1H-NMR Metabolomics of Blood Plasma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03014856
• Other study ID #: LCRP-OBNMR
• Status: Completed
• Phase: N/A
• First received: December 13, 2016
• Last updated: January 5, 2017
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2017
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Comité voor Medische Ethiek UHasselt
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Obesity
• Obesity, Pediatric
• Pediatric Obesity

Intervention

Other:
• Blood sampling
Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

References & Publications (6)

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. — View Citation

Butte NF, Liu Y, Zakeri IF, Mohney RP, Mehta N, Voruganti VS, Göring 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Wahl S, Yu Z, Kleber M, Singmann P, Holzapfel C, He Y, Mittelstrass K, Polonikov A, Prehn C, Römisch-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	metabolic phenotype of childhood obesity	Significant metabolic changes in blood plasma of obese children and adolescents and normal-weight control subjects	day 1	No
Secondary	metabolic phenotype of metabolically healthy and unhealthy obese children and adolescents	Significant metabolic changes in blood plasma of metabolically healthy obese and metabolically unhealthy obese children and adolescents	day 1	No