Obesity, PediatricNCT03014856
Metabolic Phenotypes in Childhood Obesity
An observational study of Obesity, Pediatric, run by Hasselt University.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Pediatric
- What is being tested?
- Blood sampling
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 65 overweight and obese (OB) children and 37 normal-weight (NW) controls aged 8 to 18 years
Who may be able to join
- 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
Who cannot join
- Subjects taking any medication or having serious chronic or acute illness within two weeks preceding the clinical examination,
About this study
Official title: Identification of Metabolic Phenotypes in Childhood Obesity by 1H-NMR Metabolomics of Blood Plasma
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.
Read the 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.
- Conditions
- Obesity, Pediatric
- Being tested
- Blood sampling
- Keywords
- Metabolic syndrome, Metabolomics, NMR spectroscopy
- Medical subject headings
- Pediatric Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| OB-NMR | overweight and obese children and adolescents Receives: Other: Blood sampling | |
| NMR-C | normal-weight children and adolescents Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolic phenotype of childhood obesity
Significant metabolic changes in blood plasma of obese children and adolescents and normal-weight control subjects
Measured: day 1
Secondary outcomes (1)
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
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startMay 2012
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Obesity, PediatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Peter Adriaensens, Hasselt University
- Investigators
- Peter Adriaensens, PhD, Principal investigator, Institute of Material Research, Hasselt UniversityLiene Bervoets, PhD, Study chair, Hasselt UniversityGuy Massa, PhD, MD, Study chair, Jessa HospitalWanda Guedens, PhD, Study chair, Institute of Material Research, Hasselt UniversityGunter Reekmans, Ing, Study chair, Institute of Material Research, Hasselt UniversityJean-Paul Noben, PhD, Study chair, BIOMED, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014856
- Sponsor's protocol ID
- LCRP-OBNMR
- Status last verified
- Jan 2017
- First submitted
- 13 Dec 2016
- Last updated
- 9 Jan 2017
- Results posted
- No
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.
PubMed 18007604Prince 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.
PubMed 24574347Butte 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.
PubMed 26085512Perng 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.
PubMed 25251340Mihalik 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.
PubMed 22266733Wahl 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.
PubMed 23108202Bervoets 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.
PubMed 30057787
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Metabolic Phenotypes in Childhood Obesity by 1H-NMR Metabolomics of Blood Plasma
- ClinicalTrials.gov ID
- NCT03014856
- Acronym / sponsor ID
- LCRP-OBNMR
- Conditions
- Obesity, Pediatric
- Keywords
- Metabolic syndrome, Metabolomics, NMR spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- May 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OB-NMR | – | Other: Blood samplingoverweight and obese children and adolescents |
| NMR-C | – | Other: Blood samplingnormal-weight children and adolescents |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 65 overweight and obese (OB) children and 37 normal-weight (NW) controls aged 8 to 18 years
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects taking any medication or having serious chronic or acute illness within two weeks preceding the clinical examination,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingDetermine the metabolic phenotype of blood plasma by proton-NMR spectroscopy | Other | NMR-C, OB-NMR |
Primary outcome
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
1 secondary outcome
metabolic phenotype of metabolically healthy and unhealthy obese children and adolescents
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Background: PubMed 18007604Beckonert 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.
- Background: PubMed 24574347Prince 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.
- Background: PubMed 26085512Butte 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.
- Background: PubMed 25251340Perng 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.
- Background: PubMed 22266733Mihalik 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.
- Background: PubMed 23108202Wahl 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.
- Derived from this study: PubMed 30057787Bervoets 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Adriaensens, PhD principal investigator
Institute of Material Research, Hasselt University
Liene Bervoets, PhD study chair
Hasselt University
Guy Massa, PhD, MD study chair
Jessa Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Pediatric, run by Hasselt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolic phenotype of childhood obesity (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03014856, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.